A Phase 3 interventional study of Gepotidacin and Nitrofurantoin in Urinary Tract Infections, sponsored by GlaxoSmithKline. Completed at 27 sites in Japan. Open to female participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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Among 14 studies in Urinary Tract Infections by GlaxoSmithKline — 4 open to participants now, 4 under way, none of them phase 3. Urinary Tract Infections · GlaxoSmithKline.
Among the 14 studies in Urinary Tract Infections by GlaxoSmithKline, this one is the 4th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2023, is one of 4 in phase 3, and was the 8th registered.
804 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
Browse Urinary Tract Infections studies →4 of the 14 studies in Urinary Tract Infections by GlaxoSmithKline are open now, in 2 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States
Ages 18–50 · Women only · Healthy volunteers
GlaxoSmithKline · Sites in United States, South Africa
Ages 18–64 · Healthy volunteers
GlaxoSmithKline
Ages 15–50 · Women only
GlaxoSmithKline · Sites in United States
Ages 2–11
By country, each count listing its studies:
Of the 84 Urinary Tract Infections studies recruiting now, 50 (60%) set no upper age limit and 23 (27%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 12 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 3 · Phase 3 4 · Phase 4 1
First in 2011; this study’s year is marked. 2 started in 2023.
This study's enrollment of 380 is above the median of 132 across 561 interventional studies indexed under Urinary Tract Infections.
Median enrollment 61 across the 13 interventional studies, 614 across the 1 observational. Of the 10 that completed or were terminated, 9 (90%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
3 of the studies in Urinary Tract Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07645235GlaxoSmithKlineA Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women | 2027-05-17 |
| NCT06702449GlaxoSmithKlineA Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age | 2027-05-31 |
| NCT07371429GlaxoSmithKlineA Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics | 2027-08-23 |
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Among the 14 studies in Urinary Tract Infections by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The participant has any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Gepotidacin · Drug: Placebo
Drug: Nitrofurantoin · Drug: Placebo
Gepotidacin will be administered.
Nitrofurantoin will be administered.
Placebo will be administered.
Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population
Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population
Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Therapeutic Response (TR) at the TOC Visit
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Clinical Outcome at the TOC Visit
Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Clinical Response at the TOC Visit
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Microbiological Outcome at the TOC Visit
Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Microbiological Response at the TOC Visit
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Investigator Assessed Clinical Response
Clinical response as assessed by investigator at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as sufficient resolution of acute cystitis signs and symptoms such that no additional systemic AB was required for the current infection. No apparent response to treatment, use of additional systemic AB for the current infection and death related to acute cystitis prior to the visit was considered as Clinical failure. Indeterminate/Missing was defined as participant lost to follow-up and/or the clinical assessment was not undertaken, use of confounding systemic AB for another infection, and death prior to the visit where acute cystitis was clearly noncontributory.
Time frame: At TOC visit (Days 9 to 16)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: From first dose (Day 1) to Follow-up visit (Days 21 to 31)
Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs)
An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Adverse events of special interest (AESI) for gepotidacin included clostridium difficile, cardiovascular \& gastrointestinal events and potential acetylcholinesterase-inhibition AESIs. SAEs were coded using MedDRA.
Time frame: From first dose (Day 1) to Follow-up visit (Days 21 to 31)
Number of Participants With Urinalysis Dipstick Results
Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Protein (PRO). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Positive, 2777.55 micromole per liter (µmol/l), \>=27775.5 µmol/l, 8332.65 µmol/l, 5 milligram/dl (mg/dL), 20 mg/dL, \>=80 mg/dL, 300 mg/dL, 1000 mg/dL, \>=5000 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, 2777.55 micromole per liter), GLU indicates parameter, Baseline is the visit and 2777.55 micromole per liter indicates the concentration/presence in the urine sample. Data is presented in similar way for other parameters.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate
Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF
Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QTcF. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Vital Sign: Temperature
Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Vital Sign: Pulse Rate
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Plasma Concentrations of Gepotidacin
Blood samples were collected for plasma concentration of Gepotidacin.
Time frame: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose
Urine Concentrations of Gepotidacin
Urine samples were collected for urine concentration of Gepotidacin.
Time frame: Baseline (Day 1 at 0-2h & >2h Post dose), Day 2 to 5 at Pre-dose, 0-2h & >2h Post Dose
Change From Baseline (CFB) in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Hematology Parameter-Hemoglobin Level at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Hematology Parameter- Hematocrit Level at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Hematology Parameter- Erythrocytes Count at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Hemoglobin (MCH) at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Hematology Parameter - Mean Corpuscular Volume (MCV) at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Clinical Chemistry Parameters - Calcium, Glucose, Potassium, Magnesium, Phosphate, Sodium, and Urea Nitrogen Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Clinical Chemistry Parameters - Serum Chloride at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Clinical Chemistry Parameters - Direct Bilirubin, Total Bilirubin and Creatinine Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Clinical Chemistry Parameters - Creatinine Clearance at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Clinical Chemistry Parameters - Albumin and Protein Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Clinical Chemistry Parameters - Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
Change From Baseline (CFB) in Clinical Chemistry Parameter - Aspartate Aminotransferase (AST) Levels at On Therapy and Test of Cure Visit
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
Time frame: Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16)
| Milestone | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Started | 286 | 94 |
| Itt population | 281 | 93 |
| Microbiological itt (micro-itt) | 88 | 29 |
| Micro-itt ntf-s | 83 | 25 |
| Micro-itt mdr | 18 | 3 |
| Safety | 281 | 93 |
| Completed | 279 | 92 |
| Not completed | 7 | 2 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 |
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
| Participants | Gepotidacin |
|---|---|
| Therapeutic Success | 69 |
| Therapeutic Failure | 14 |
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Therapeutic Success | 69 | 17 |
| Therapeutic Failure | 14 | 8 |
Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Clinical Resolution | 71 | 19 |
| Clinical Improvement | 5 | 4 |
| Clinical Worsening | 3 | 2 |
| Unable To Determine | 4 | 0 |
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Clinical Success | 71 | 19 |
| Clinical Failure | 12 | 6 |
Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Microbiological Eradication (ME) | 74 | 20 |
| Microbiological Persistence (MP) | 0 | 0 |
| Microbiological Recurrence (MR) | 1 | 3 |
| Unable To Determine (UTD) | 8 | 2 |
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Microbiological Success | 74 | 20 |
| Microbiological Failure | 9 | 5 |
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Therapeutic Success | 14 | 2 |
| Therapeutic Failure | 4 | 1 |
Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met).
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Clinical Resolution | 14 | 2 |
| Clinical Improvement | 2 | 0 |
| Clinical Worsening | 1 | 1 |
| Unable To Determine | 1 | 0 |
Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Clinical Success | 14 | 2 |
| Clinical Failure | 4 | 1 |
Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Microbiological Eradication | 16 | 2 |
| Microbiological Persistence | 0 | 0 |
| Microbiological Recurrence | 0 | 0 |
| Unable To Determine | 2 | 1 |
Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Microbiological Success | 16 | 2 |
| Microbiological Failure | 2 | 1 |
Clinical response as assessed by investigator at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as sufficient resolution of acute cystitis signs and symptoms such that no additional systemic AB was required for the current infection. No apparent response to treatment, use of additional systemic AB for the current infection and death related to acute cystitis prior to the visit was considered as Clinical failure. Indeterminate/Missing was defined as participant lost to follow-up and/or the clinical assessment was not undertaken, use of confounding systemic AB for another infection, and death prior to the visit where acute cystitis was clearly noncontributory.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Clinical Success | 242 | 86 |
| Clinical Failure | 28 | 6 |
| Indeterminate/Missing | 11 | 1 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA).
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 201 | 18 |
An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Adverse events of special interest (AESI) for gepotidacin included clostridium difficile, cardiovascular \& gastrointestinal events and potential acetylcholinesterase-inhibition AESIs. SAEs were coded using MedDRA.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Serious AE (SAE) | 2 | 0 |
| AE of Special Interest (AESIs) | 191 | 12 |
Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Protein (PRO). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Positive, 2777.55 micromole per liter (µmol/l), \>=27775.5 µmol/l, 8332.65 µmol/l, 5 milligram/dl (mg/dL), 20 mg/dL, \>=80 mg/dL, 300 mg/dL, 1000 mg/dL, \>=5000 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, 2777.55 micromole per liter), GLU indicates parameter, Baseline is the visit and 2777.55 micromole per liter indicates the concentration/presence in the urine sample. Data is presented in similar way for other parameters.
| Participants | Gepotidacin | Nitrofurantoin |
|---|---|---|
| GLU, Baseline, 2777.55 micromole per liter | 3 | 1 |
| GLU, Baseline, >=27775.5 micromole per liter | 4 | 5 |
| GLU, Baseline, NEGATIVE | 273 | 87 |
| GLU, On-Therapy, 2777.55 micromole per liter | 5 | 1 |
| GLU, On-Therapy, 8332.65 micromole per liter | 2 | 0 |
| GLU, On-Therapy, >=27775.5 micromole per liter | 2 | 6 |
| GLU, On-Therapy, NEGATIVE | 266 | 86 |
| GLU, Test-of-Cure, 2777.55 micromole per liter | 1 | 3 |
| GLU, Test-of-Cure, 8332.65 micromole per liter | 1 | 0 |
| GLU, Test-of-Cure, >=27775.5 micromole per liter | 3 | 6 |
| GLU, Test-of-Cure, NEGATIVE | 267 | 83 |
| KET, Baseline, 20 milligrams per deciliter | 10 | 1 |
| KET, Baseline, 5 milligrams per deciliter | 26 | 13 |
| KET, Baseline, NEGATIVE | 244 | 79 |
| KET, On-Therapy, 20 milligrams per deciliter | 6 | 1 |
| KET, On-Therapy, 5 milligrams per deciliter | 22 | 7 |
| KET, On-Therapy, >=80 milligrams per deciliter | 0 | 1 |
| KET, On-Therapy, NEGATIVE | 247 | 84 |
| KET, Test-of-Cure, 20 milligrams per deciliter | 1 | 0 |
| KET, Test-of-Cure, 5 milligrams per deciliter | 18 | 13 |
| KET, Test-of-Cure, NEGATIVE | 253 | 79 |
| NIT, Baseline, NEGATIVE | 212 | 75 |
| NIT, Baseline, POSITIVE | 68 | 18 |
| NIT, On-Therapy, NEGATIVE | 275 | 90 |
| NIT, On-Therapy, POSITIVE | 0 | 3 |
| NIT, Test-of-Cure, NEGATIVE | 256 | 86 |
| NIT, Test-of-Cure, POSITIVE | 16 | 6 |
| PRO, Baseline, 1000 milligrams per deciliter | 43 | 19 |
| PRO Baseline, 300 milligrams per deciliter | 63 | 25 |
| PRO, Baseline, >=5000 milligrams per deciliter | 15 | 4 |
| PRO, Baseline, NEGATIVE | 159 | 45 |
| PRO, On-Therapy, 1000 milligrams per deciliter | 12 | 1 |
| PRO, On-Therapy, 300 milligrams per deciliter | 46 | 17 |
| PRO, On-Therapy, >=5000 milligrams per deciliter | 2 | 0 |
| PRO, On-Therapy, NEGATIVE | 215 | 75 |
| PRO, Test-of-Cure, 1000 milligrams per deciliter | 13 | 1 |
| PRO, Test-of-Cure, 300 milligrams per deciliter | 24 | 11 |
| PRO, Test-of-Cure, >=5000 milligrams per deciliter | 0 | 1 |
| PRO, Test-of-Cure, NEGATIVE | 235 | 79 |
Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Baseline is defined as the latest pre-dose assessment with a non-missing value.
| beats/minute | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 67.2 ± 10.18 | 70.7 ± 13.29 |
| CFB to On-Therapy | -0.5 ± 7.84 | -3.3 ± 12.41 |
| CFB to Test-of-Cure | 0.5 ± 8.44 | -1.6 ± 12.90 |
Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QTcF. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Millisecond (msec) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| PR, Baseline | 154.9 ± 17.88 | 159.3 ± 16.68 |
| PR, CFB to On-Therapy | 1.6 ± 12.18 | 1.4 ± 9.96 |
| PR, CFB to Test-of-Cure | 0.3 ± 10.47 | 0.6 ± 10.49 |
| QRS, Baseline | 88.1 ± 10.06 | 89.8 ± 9.78 |
| QRS, CFB to On-Therapy | 1.2 ± 3.77 | 0.0 ± 3.57 |
| QRS, CFB to Test-of-Cure | -0.6 ± 3.72 | -0.5 ± 3.57 |
| QT, Baseline | 404.5 ± 28.16 | 401.1 ± 28.22 |
| QT, CFB to On-Therapy | 10.4 ± 23.67 | 4.8 ± 18.78 |
| QT, CFB to Test-of-Cure | -0.7 ± 24.53 | 3.4 ± 23.23 |
| QTcF, Baseline | 418.3 ± 17.75 | 423.2 ± 17.25 |
| QTcF, CFB to On-Therapy | 10.3 ± 13.44 | 1.8 ± 10.82 |
| QTcF, CFB to Test-of-Cure | 1.3 ± 12.09 | 3.6 ± 11.66 |
SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Millimeters of mercury (mmHg) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Diastolic Blood Pressure, Baseline | 72.8 ± 11.98 | 74.5 ± 12.60 |
| Diastolic Blood Pressure, CFB to On-Therapy | -2.6 ± 9.45 | -2.1 ± 9.36 |
| Diastolic Blood Pressure, CFB to Test-of-Cure | -2.4 ± 9.76 | -3.9 ± 9.64 |
| Systolic Blood Pressure, Baseline | 118.2 ± 18.10 | 118.7 ± 18.38 |
| Systolic Blood Pressure, CFB to On-Therapy | -3.1 ± 12.20 | -3.3 ± 13.32 |
| Systolic Blood Pressure, CFB to Test-of-Cure | -3.7 ± 11.63 | -4.1 ± 11.35 |
Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Celsius | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 36.49 ± 0.367 | 36.44 ± 0.365 |
| CFB to On-Therapy | -0.05 ± 0.453 | -0.03 ± 0.425 |
| CFB to Test-of-Cure | -0.07 ± 0.397 | -0.02 ± 0.396 |
Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| beats/minute | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 69.7 ± 10.79 | 72.2 ± 10.65 |
| CFB to On-Therapy | 2.4 ± 10.36 | 1.4 ± 10.66 |
| CFB to Test-of-Cure | 0.4 ± 9.30 | -0.5 ± 11.54 |
Blood samples were collected for plasma concentration of Gepotidacin.
| Nanogram/ milliliter (ng/mL) | Gepotidacin |
|---|---|
| Baseline, POST-DOSE, Day 1, 0-2h | 5210.23 ± 3428.432 |
| Baseline, POST-DOSE, Day 1, >2h | 5251.54 ± 2097.649 |
| On-Therapy, PRE-DOSE, Day 2-5, pre-dose | 1960.14 ± 16752.767 |
| On-Therapy, POST-DOSE, Day 2-5, 0-2h | 17548.67 ± 124724.240 |
| On-Therapy, POST-DOSE, Day 2-5, >2h | 5976.40 ± 5142.635 |
Urine samples were collected for urine concentration of Gepotidacin.
| Microgram/ milliliter (ug/mL) | Gepotidacin |
|---|---|
| Baseline, POST-DOSE, Day 1, 0-2h | 506.988 ± 914.3140 |
| Baseline, POST-DOSE, Day 1, >2h | 600.729 ± 644.2265 |
| On-Therapy, PRE-DOSE, Day 2-5, pre-dose | 492.096 ± 565.8822 |
| On-Therapy, POST-DOSE, Day 2-5, 0-2h | 901.554 ± 1451.8781 |
| On-Therapy, POST-DOSE, Day 2-5, >2h | 1138.900 ± 1429.7998 |
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Giga cells per Liter (10^9 cells/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Basophils, Baseline | 0.050 ± 0.0238 | 0.051 ± 0.0223 |
| Basophils, CFB to On-Therapy | -0.004 ± 0.0194 | -0.001 ± 0.0152 |
| Basophils, CFB to Test-of-Cure | -0.001 ± 0.0192 | -0.002 ± 0.0135 |
| Eosinophils, Baseline | 0.134 ± 0.1199 | 0.121 ± 0.0977 |
| Eosinophils, CFB to On-Therapy | 0.008 ± 0.0567 | 0.011 ± 0.0500 |
| Eosinophils, CFB to Test-of-Cure | 0.028 ± 0.0862 | 0.023 ± 0.0630 |
| Lymphocytes, Baseline | 1.657 ± 0.5001 | 1.727 ± 0.5203 |
| Lymphocytes, CFB to On-Therapy | -0.044 ± 0.3958 | 0.075 ± 0.4024 |
| Lymphocytes, CFB to Test-of-Cure | -0.054 ± 0.4698 | 0.111 ± 0.4414 |
| Monocytes, Baseline | 0.388 ± 0.1474 | 0.375 ± 0.1394 |
| Monocytes, CFB to On-Therapy | -0.057 ± 0.1457 | -0.059 ± 0.1584 |
| Monocytes, CFB to Test-of-Cure | -0.049 ± 0.1503 | -0.033 ± 0.1393 |
| Neutrophils, Baseline | 4.805 ± 2.1102 | 4.684 ± 2.0992 |
| Neutrophils, CFB to On-Therapy | -1.530 ± 1.8841 | -1.477 ± 1.9168 |
| Neutrophils, CFB to Test-of-Cure | -1.713 ± 2.2275 | -1.493 ± 2.1633 |
| Platelets, Baseline | 261.0 ± 58.37 | 253.6 ± 56.80 |
| Platelets, CFB to On-Therapy | 5.7 ± 25.42 | 2.6 ± 21.53 |
| Platelets, CFB to Test-of-Cure | 3.3 ± 34.80 | 4.2 ± 37.13 |
Blood samples were collected for the analysis of hemoglobin level. Baseline is defined as the latest pre-dose assessment with a non-missing value
| Grams per Liter (g/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 128.6 ± 10.70 | 128.0 ± 10.91 |
| CFB to On-Therapy | -1.3 ± 6.01 | -1.0 ± 5.61 |
| CFB to Test-of-Cure | -2.3 ± 6.22 | -2.9 ± 6.39 |
Blood samples were collected for the analysis of hematocrit level. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Proportion of red blood cells in blood | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 0.4355 ± 0.04242 | 0.4308 ± 0.05058 |
| CFB to On-Therapy | -0.0047 ± 0.03252 | 0.0067 ± 0.03567 |
| CFB to Test-of-Cure | -0.0082 ± 0.03441 | -0.0038 ± 0.03533 |
Blood samples were collected for the analysis of erythrocytes count. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Tera cells per Liter (10^12 cells/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 4.302 ± 0.3650 | 4.245 ± 0.3758 |
| CFB to On-Therapy | -0.040 ± 0.2021 | -0.025 ± 0.1887 |
| CFB to Test-of-Cure | -0.085 ± 0.2157 | -0.098 ± 0.2218 |
Blood samples were collected for the analysis of MCH. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Picogram (pg) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 29.97 ± 2.062 | 30.26 ± 2.170 |
| CFB to On-Therapy | -0.03 ± 0.536 | -0.05 ± 0.519 |
| CFB to Test-of-Cure | 0.04 ± 0.613 | 0.00 ± 0.629 |
Blood samples were collected for the analysis of MCV. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Femtoliter (fL) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 101.48 ± 8.607 | 101.65 ± 10.185 |
| CFB to On-Therapy | -0.16 ± 6.300 | 2.40 ± 7.634 |
| CFB to Test-of-Cure | 0.08 ± 6.740 | 1.61 ± 7.071 |
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| millimoles per liter (mmol/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Calcium, Baseline | 2.319018 ± 0.0816980 | 2.314716 ± 0.0868299 |
| Calcium, CFB to On-Therapy | -0.004536 ± 0.0766926 | -0.012341 ± 0.0695672 |
| Calcium, CFB to Test-of-Cure | -0.032315 ± 0.0855497 | -0.029885 ± 0.0860459 |
| Glucose, Baseline | 5.196605 ± 1.1351979 | 5.458483 ± 1.7589320 |
| Glucose, CFB to On-Therapy | 0.248377 ± 1.3575780 | 0.423189 ± 1.3092369 |
| Glucose, CFB to Test-of-Cure | 0.057763 ± 1.1507851 | 0.156160 ± 1.2016889 |
| Potassium, Baseline | 4.13 ± 0.339 | 4.16 ± 0.364 |
| Potassium, CFB to On-Therapy | 0.05 ± 0.329 | 0.02 ± 0.310 |
| Potassium, CFB to Test-of-Cure | 0.00 ± 0.365 | 0.04 ± 0.370 |
| Magnesium, Baseline | 0.862 ± 0.0605 | 0.860 ± 0.0632 |
| Magnesium, CFB to On-Therapy | -0.004 ± 0.0555 | -0.010 ± 0.0519 |
| Magnesium, CFB to Test-of-Cure | -0.010 ± 0.0569 | -0.014 ± 0.0651 |
| Phosphate, Baseline | 1.184963 ± 0.1593757 | 1.206882 ± 0.1775576 |
| Phosphate, CFB to On-Therapy | 0.009746 ± 0.1600765 | -0.031943 ± 0.1706300 |
| Phosphate, CFB to Test-of-Cure | 0.019541 ± 0.1736731 | 0.036903 ± 0.1985578 |
| Sodium, Baseline | 139.8 ± 2.25 | 139.8 ± 2.13 |
| Sodium, CFB to On-Therapy | 0.1 ± 2.33 | -0.2 ± 2.38 |
| Sodium, CFB to Test-of-Cure | 0.1 ± 2.52 | 0.2 ± 2.42 |
| Urea Nitrogen, Baseline | 4.3094 ± 1.32217 | 4.4145 ± 1.33139 |
| Urea Nitrogen, CFB to On-Therapy | -0.0948 ± 0.98541 | -0.1689 ± 0.85458 |
| Urea Nitrogen, CFB to Test-of-Cure | 0.1423 ± 1.07780 | 0.1177 ± 0.91259 |
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value
| Milliequivalents per liter (mEq/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 102.3 ± 2.21 | 102.4 ± 2.38 |
| CFB to On-Therapy | 0.8 ± 2.23 | 0.3 ± 2.36 |
| CFB to Test-of-Cure | 1.0 ± 2.46 | 0.6 ± 2.58 |
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| micromoles per Liter (umol/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Direct Bilirubin, Baseline | 3.4498 ± 0.23845 | 3.4329 ± 0.10767 |
| Direct Bilirubin, CFB to On-Therapy | -0.0056 ± 0.24374 | -0.0129 ± 0.10767 |
| Direct Bilirubin, CFB to Test-of-Cure | -0.0063 ± 0.20804 | -0.0113 ± 0.11053 |
| Total Bilirubin, Baseline | 7.0731 ± 4.66102 | 6.0420 ± 3.11713 |
| Total Bilirubin, CFB to On-Therapy | -0.4079 ± 4.14317 | 0.3163 ± 3.23527 |
| Total Bilirubin, CFB to Test-of-Cure | -0.1723 ± 4.23182 | 0.2988 ± 2.99514 |
| Creatinine, Baseline | 50.964 ± 8.7527 | 52.280 ± 11.9212 |
| Creatinine, CFB to On-Therapy | 3.632 ± 6.6395 | -1.426 ± 6.9325 |
| Creatinine, CFB to Test-of-Cure | 0.620 ± 7.9007 | 0.000 ± 7.0965 |
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Milliliter/second (mL/s) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 1.8346749 ± 0.58199842 | 1.8690338 ± 0.63944090 |
| CFB to On-Therapy | -0.1155781 ± 0.27838072 | 0.0331548 ± 0.28390850 |
| CFB to Test-of-Cure | -0.0284139 ± 0.27653678 | -0.0111724 ± 0.24923906 |
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| gram per Liter (g/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Albumin, Baseline | 44.7 ± 2.51 | 44.1 ± 2.91 |
| Albumin, CFB to On-Therapy | -0.4 ± 2.19 | -0.3 ± 2.11 |
| Albumin, CFB to Test-of-Cure | -1.3 ± 2.36 | -1.2 ± 2.26 |
| Protein, Baseline | 70.6 ± 4.18 | 70.7 ± 4.46 |
| Protein, CFB to On-Therapy | -0.8 ± 3.50 | -0.7 ± 3.71 |
| Protein, CFB to Test-of-Cure | -2.1 ± 3.80 | -2.3 ± 3.72 |
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| International Units per Liter (IU/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| ALP, Baseline | 68.9 ± 22.09 | 68.4 ± 22.18 |
| ALP, CFB to On-Therapy | -0.1 ± 6.10 | -0.4 ± 8.10 |
| ALP, CFB to Test-of-Cure | -2.9 ± 7.12 | -3.1 ± 9.28 |
| ALT, Baseline | 17.0 ± 16.80 | 16.7 ± 11.11 |
| ALT, CFB to On-Therapy | 1.2 ± 6.16 | -0.2 ± 3.28 |
| ALT, CFB to Test-of-Cure | 0.6 ± 12.59 | -1.1 ± 5.98 |
Blood samples were collected for the analysis of clinical chemistry parameters. Baseline is defined as the latest pre-dose assessment with a non-missing value.
| Units per Liter (U/L) | Gepotidacin | Nitrofurantoin |
|---|---|---|
| Baseline | 20.1 ± 17.26 | 18.7 ± 7.12 |
| CFB to On-Therapy | 0.4 ± 11.28 | 0.0 ± 3.85 |
| CFB to Test-of-Cure | 0.8 ± 16.01 | -0.2 ± 4.49 |
Collected over All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from first dose (Day 1) to follow-up visit (Days 21 to 31).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gepotidacin | 0/281 (0%) | 2/281 (0.7%) | 174/281 (61.9%) |
| Nitrofurantoin | 0/93 (0%) | 0/93 (0%) | 8/93 (8.6%) |
| Event | Gepotidacin | Nitrofurantoin |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/281 | 0/93 |
| VomitingGastrointestinal disorders | 1/281 | 0/93 |
| Clostridium difficile infectionInfections and infestations | 1/281 | 0/93 |
| Event | Gepotidacin | Nitrofurantoin |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 167/281 | 7/93 |
| NauseaGastrointestinal disorders | 35/281 | 2/93 |
ITT population: All participants (except for 6 participants from the site with GCP violation) were randomly assigned to the study treatment.
| Age, Continuous(YEARS) | Gepotidacin | Nitrofurantoin | Total |
|---|---|---|---|
| Mean | 44.9 ± 18.78 | 46.4 ± 19.21 | 45.2 ± 18.88 |
| Sex: Female, Male(Participants) | Gepotidacin | Nitrofurantoin | Total |
|---|---|---|---|
| Female | 281 | 93 | 374 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Gepotidacin | Nitrofurantoin | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 281 | 93 | 374 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk.com
Ran from Jan 2023 to primary completion in Feb 2024, 12 months.
Results were first posted in Mar 2025, 1 year 1 month after primary completion.
Of 23 industry-sponsored phase 3 interventional studies under Urinary Tract Infections, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 12 months is below that.
Counting every sponsor, half of 37 studies reached it within 20 months; a quarter within 14 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gepotidacin