A Phase 3 interventional study of TBP-PI-HBr and Imipenem-cilastatin in Urinary Tract Infection and Acute Pyelonephritis, sponsored by Spero Therapeutics. Completed at 85 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Spero Therapeutics · Phase 3, Interventional, and Treatment
The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (greater than or equal to (≥)18 years of age) with cUTI or AP.
The study included a pre-planned interim analysis with stopping criteria for efficacy and futility that was performed by an independent data monitoring committee (IDMC). For full details please refer to the protocol and statistical analysis plan.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 1,690 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Spero Therapeutics is the lead sponsor of 22 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 3 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria as per protocol may apply.
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
Participants received TBP-PI-HBr 600 milligrams (mg), two x 300mg film-coated tablets, orally (PO) and a dummy infusion intravenously (IV), every 6 hours (q6h) from Day 1 through Day 10. Participants with estimated baseline creatinine clearance (CrCl) greater than (\>) 30 millilitres per minute (mL/min) and less than or equal to (≤) 50 mL/min received TBP-PI-HBr 300 mg q6h.
Drug: TBP-PI-HBr · Drug: Dummy Infusion
Participants received imipenem-cilastatin 500 mg, IV and matched dummy tablets, PO, q6h from Day 1 through Day 10. Dose adjustments for imipenem-cilastatin were made for participants with estimated baseline CrCl less than (\<) 90mL/min per approved imipenem-cilastatin package insert. Participants with baseline CrCl levels greater than or equal to (≥) 60 to \< 90 mL/min were administered imipenem-cilastatin, 400 mg IV q6h and participants with baseline CrCl levels \>30 to \<60 mL/min, were administered 300mg IV, q6h.
Drug: Imipenem-cilastatin · Drug: Dummy Tablets
TBP-PI-HBr film-coated immediate-release tablets.
Also known as: SPR994
Sterile powder for reconstitution administered as IV.
0.9% sodium chloride administered as IV infusion.
TBP-PI-HBr matching dummy tablets.
Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
Time frame: At Day 17 (TOC)
Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
Time frame: At Day 17 (TOC)
Number of Participants With Overall Response at the End-of-Treatment (EOT) and Late Follow-Up (LFU) Visits in the Micro-ITT Population
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
Time frame: At Day 10 (EOT) and Day 28 (LFU)
Number of Participants With Overall Response at EOT and LFU Visits in the ME Population
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
Time frame: At Day 10 (EOT) and Day 28 (LFU)
Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the Micro-ITT Population
Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse.
Time frame: At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU)
Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the CE Population
Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse.
Time frame: At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU)
Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the ME Population
Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse.
Time frame: At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU)
Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the Micro-ITT Population
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, defined as reduction of Baseline uropathogens to \<10\^3 CFU/mL on urine culture and negative repeated blood culture (if blood culture was positive at Baseline) ;Persistence, defined as Isolation from urine culture of ≥10\^3 CFU/mL or from blood of any of the Baseline uropathogen(s) identified at study entry; Indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason.
Time frame: At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU)
Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the ME Population
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, defined as reduction of baseline uropathogens to \<10\^3 CFU/mL on urine culture and negative repeated blood culture (if blood culture was positive at Baseline); Persistence, defined as Isolation from urine culture of ≥10\^3 CFU/mL or from blood of any of the Baseline uropathogen(s) identified at study entry; Indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason.
Time frame: At Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU)
Number of Participants With Overall Response at EOT, TOC, and LFU Visits in Participants With Drug-Resistant Enterobacterales in Micro-ITT Population
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
Time frame: Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU)
Number of Participants With Overall Response at EOT, TOC, and LFU Visits in Participants With Drug-Resistant Enterobacterales in the ME Population
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
Time frame: Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU)
Number of Participants With Clinical Response at the EOT and TOC Visits in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure (defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted); Failure, including clinical relapse (defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI); or Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
Time frame: Day 10 (EOT) and Day 17 (TOC)
Number of Participants With Clinical Response at the LFU Visit in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure (defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted); Failure, including clinical relapse (defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI); or Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
Time frame: At Day 28 (LFU)
Number of Participants With Clinical Response at the EOT, TOC and LFU Visits in Participants With Drug-resistant Enterobacterales in the ME Population
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure: Sustained clinical cure is defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted; Failure, including clinical relapse: Clinical relapse is defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI; Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
Time frame: Day 10 (EOT), Day 17 (TOC) and Day 28(LFU)
Number of Participants With Microbiological Response at the EOT and TOC Visits in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, including sustained microbiologic eradication, i.e.,microbiologic eradication at TOC and no subsequent urine culture after TOC demonstrating recurrence of original Baseline uropathogen at ≥10\^3 CFU/mL;Persistence, including microbiologic recurrence, i.e.,isolation from urine culture at ≥10\^3 CFU/mL or blood culture of any of Baseline uropathogen(s) at any time after documented eradication at TOC visit up to and including LFU visit; Microbiologic indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. If a participant is assessed as a microbiological persistence at EOT, participant is automatically considered persistent at TOC and LFU. If assessed as persistent at TOC, participant is automatically considered a persistent at LFU.
Time frame: Day 10 (EOT) and Day 17 (TOC)
Number of Participants With Microbiological Response at the LFU Visit in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure: Sustained clinical cure is defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted; Failure, including clinical relapse: Clinical relapse is defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI; Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
Time frame: At Day 28 (LFU)
Number of Participants With Microbiological Response at the EOT and TOC Visits in Participants With Drug-resistant Enterobacterales in the ME Population
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, including sustained microbiologic eradication, i.e.,microbiologic eradication at TOC and no subsequent urine culture after TOC demonstrating recurrence of original Baseline uropathogen at ≥10\^3 CFU/mL;Persistence, including microbiologic recurrence, i.e.,isolation from urine culture at ≥10\^3 CFU/mL or blood culture of any of Baseline uropathogen(s) at any time after documented eradication at TOC visit up to and including LFU visit; Microbiologic indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. If a participant is assessed as a microbiological persistence at EOT, participant is automatically considered persistent at TOC and LFU. If assessed as persistent at TOC, participant is automatically considered a persistent at LFU.
Time frame: Day 10 (EOT) and Day 17 (TOC)
Number of Participants With Microbiological Response at the LFU Visit in Participants With Drug-resistant Enterobacterales in the ME Population
Participants will be evaluated for microbiological response based on blood and urine cultures as :Eradication, including sustained microbiologic eradication, i.e., microbiologic eradication at TOC and no subsequent urine culture after TOC demonstrating recurrence of original Baseline uropathogen at ≥10\^3 CFU/mL;Persistence, including microbiologic recurrence, i.e.,isolation from urine culture at ≥10\^3 CFU/mL or blood culture of any of Baseline uropathogen(s) at any time after documented eradication at TOC visit up to and including LFU visit; Microbiologic indeterminate:no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. If a participant is assessed as a microbiological persistence at EOT,participant is automatically considered persistent at TOC and LFU. If assessed as persistent at TOC, participant is automatically considered a persistent at LFU.
Time frame: At Day 28 (LFU)
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational/experimental) product, whether or not related to this product. Serious Adverse Event (SAE) is any AE occurring at any dose and regardless of causality that results in death, is life threatening, requires immediate or prolongation of hospitalization, results in significant disability, congenital anomaly and is a medically important reaction. TEAEs are defined as events that are newly occurring or worsening from the time of the first dose of IP through LFU.
Time frame: From first dose of study drug (Day 1) up to last follow-up visit (Day 28)
Plasma Concentrations of TBP-PI-HBr
Time frame: 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 4h and 6h postdose at Day 2
The planned enrollment for the full study was 2648 participants. As specified in the protocol, a pre-planned interim analysis occurred when approximately 60% of participants reached the test-of-cure visit. The study met the primary endpoint for efficacy at the interim analysis and the study was stopped. Enrollment was paused during the interim analysis. Therefore, a total of 1690 participants were enrolled in the study at various investigative sites from 21 Dec 2023 to 06 Feb 2025.
| Milestone | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| Started | 844 | 846 |
| Itt population | 844 | 846 |
| Micro-itt population | 446 | 483 |
| Completed | 810 | 818 |
| Not completed | 34 | 28 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lost to follow-up | 8 | 4 |
| Withdrew: Participant noncompliance/uncooperativeness | 7 | 7 |
| Withdrew: Protocol deviation | 0 | 1 |
| Withdrew: Subject withdrawal of consent | 16 | 14 |
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| Responder | 261 | 291 |
| Non-responder | 171 | 179 |
| Indeterminate | 14 | 13 |
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| Responder | 250 | 282 |
| Non-responder | 160 | 170 |
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT — Responders | 426 | 454 |
| EOT — Non-responders | 10 | 14 |
| EOT — Indeterminate | 10 | 15 |
| LFU — Responders | 214 | 257 |
| LFU — Non-responders | 222 | 219 |
| LFU — Indeterminate | 10 | 7 |
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT — Responder | 423 | 454 |
| EOT — Non-responder | 5 | 12 |
| LFU — Responder | 204 | 239 |
| LFU — Non-responder | 202 | 200 |
Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT — Clinical Cure | 438 | 477 |
| EOT — Clinical Failure | 7 | 6 |
| EOT — Clinical Indeterminate | 1 | 0 |
| TOC — Clinical Cure | 417 | 460 |
| TOC — Clinical Failure | 20 | 16 |
| TOC — Clinical Indeterminate | 9 | 7 |
| LFU — Clinical Cure | 392 | 428 |
| LFU — Clinical Failure | 43 | 46 |
| LFU — Clinical Indeterminate | 11 | 9 |
Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT — Clinical Cure | 824 | 824 |
| EOT — Clinical Failure | 9 | 14 |
| TOC — Clinical Cure | 753 | 763 |
| TOC — Clinical Failure | 31 | 35 |
| LFU — Clinical Cure | 707 | 692 |
| LFU — Clinical Failure | 64 | 74 |
Clinical response at EOT and TOC is based on the Investigator's assessment of changes in baseline cUTI/AP signs and symptoms. Clinical cure: complete resolution or marked improvement of baseline symptoms with no new symptoms and no need for additional antimicrobial therapy. Clinical failure: baseline symptoms not fully resolved, new symptoms occur requiring non-study antibiotics, or death. Clinical indeterminate: insufficient data to classify response (e.g., lost to follow-up or missing data). Clinical response at LFU is based on change from baseline. Cure, including sustained clinical cure: met cure criteria at TOC and remained free of new or recurrent cUTI/AP symptoms at LFU with no need for further antibiotics. Failure, including clinical relapse: met cure criteria at TOC but developed new cUTI/AP symptoms at LFU requiring antibiotics. Clinical indeterminate: insufficient data to classify as sustained cure or relapse.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT — Clinical Cure | 426 | 462 |
| EOT — Clinical Failure | 2 | 4 |
| TOC — Clinical Cure | 396 | 442 |
| TOC — Clinical Failure | 14 | 10 |
| LFU — Clinical Cure | 371 | 399 |
| LFU — Clinical Failure | 35 | 40 |
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, defined as reduction of Baseline uropathogens to \<10\^3 CFU/mL on urine culture and negative repeated blood culture (if blood culture was positive at Baseline) ;Persistence, defined as Isolation from urine culture of ≥10\^3 CFU/mL or from blood of any of the Baseline uropathogen(s) identified at study entry; Indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT — Microbiologic Eradication | 428 | 457 |
| EOT — Microbiologic Persistence | 3 | 9 |
| EOT — Microbiologic Indeterminate | 15 | 17 |
| TOC — Microbiologic Eradication | 269 | 296 |
| TOC — Microbiologic Persistence | 158 | 169 |
| TOC — Microbiologic Indeterminate | 19 | 18 |
| LFU — Microbiologic Eradication | 224 | 270 |
| LFU — Microbiologic Persistence | 207 | 202 |
| LFU — Microbiologic Indeterminate | 15 | 11 |
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, defined as reduction of baseline uropathogens to \<10\^3 CFU/mL on urine culture and negative repeated blood culture (if blood culture was positive at Baseline); Persistence, defined as Isolation from urine culture of ≥10\^3 CFU/mL or from blood of any of the Baseline uropathogen(s) identified at study entry; Indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT — Microbiologic Eradication | 425 | 457 |
| EOT — Microbiologic Persistence | 3 | 9 |
| TOC — Microbiologic Eradication | 257 | 287 |
| TOC — Microbiologic Persistence | 153 | 165 |
| LFU — Microbiologic Eradication | 213 | 251 |
| LFU — Microbiologic Persistence | 193 | 188 |
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT: Extended spectrum beta-lactamase (ESBL)-Phenotype — Responder | 156 | 175 |
| EOT: Extended spectrum beta-lactamase (ESBL)-Phenotype — Non-responder | 1 | 6 |
| EOT: Extended spectrum beta-lactamase (ESBL)-Phenotype — Indeterminate | 4 | 9 |
| EOT: Fluoroquinolone-not susceptible (FQ-NS) — Responder | 190 | 199 |
| EOT: Fluoroquinolone-not susceptible (FQ-NS) — Non-responder | 2 | 5 |
| EOT: Fluoroquinolone-not susceptible (FQ-NS) — Indeterminate | 6 | 6 |
| EOT: Trimethoprim-sulfamethoxazole-resistant (TMP-SMX-R) — Responder | 178 | 191 |
| EOT: Trimethoprim-sulfamethoxazole-resistant (TMP-SMX-R) — Non-responder | 1 | 5 |
| EOT: Trimethoprim-sulfamethoxazole-resistant (TMP-SMX-R) — Indeterminate | 3 | 7 |
| TOC: ESBL-Phenotype — Responder | 84 | 108 |
| TOC: ESBL-Phenotype — Non-responder | 71 | 76 |
| TOC: ESBL-Phenotype — Indeterminate | 6 | 6 |
| TOC: FQ-NS — Responder | 98 | 119 |
| TOC: FQ-NS — Non-responder | 92 | 85 |
| TOC: FQ-NS — Indeterminate | 8 | 6 |
| TOC: TMP-SMX-R — Responder | 102 | 114 |
| TOC: TMP-SMX-R — Non-responder | 75 | 81 |
| TOC: TMP-SMX-R — Indeterminate | 5 | 8 |
| LFU: ESBL-Phenotype — Responder | 68 | 100 |
| LFU: ESBL-Phenotype — Non-responder | 90 | 88 |
| LFU: ESBL-Phenotype — Indeterminate | 3 | 2 |
| LFU: FQ-NS — Responder | 79 | 107 |
| LFU: FQ-NS — Non-responder | 115 | 101 |
| LFU: FQ-NS — Indeterminate | 4 | 2 |
| LFU: TMP-SMX-R — Responder | 85 | 101 |
| LFU: TMP-SMX-R — Non-responder | 96 | 98 |
| LFU: TMP-SMX-R — Indeterminate | 1 | 4 |
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Participants | TBP-PI-HBr 600 mg | Imipenem-cilastatin 500 mg |
|---|---|---|
| EOT: ESBL-Phenotype — Responder | 156 | 175 |
| EOT: ESBL-Phenotype — Non-Responder | 1 | 4 |
| EOT: FQ-NS — Responder | 190 | 199 |
| EOT: FQ-NS — Non-Responder | 1 | 4 |
| EOT: TMP-SMX-R — Responder | 177 | 191 |
| EOT: TMP-SMX-R — Non-Responder | 0 | 5 |
| TOC: ESBL-Phenotype — Responder | 83 | 106 |
| TOC: ESBL-Phenotype — Non-Responder | 69 | 71 |
| TOC: FQ-NS — Responder | 96 | 117 |
| TOC: FQ-NS — Non-Responder | 90 | 82 |
| TOC: TMP-SMX-R — Responder | 100 | 112 |
| TOC: TMP-SMX-R — Non-Responder | 72 | 77 |
| LFU: ESBL-Phenotype — Responder | 66 | 94 |
| LFU: ESBL-Phenotype — Non-Responder | 85 | 78 |
| LFU: FQ-NS — Responder | 78 | 99 |
| LFU: FQ-NS — Non-Responder | 108 | 93 |
| LFU: TMP-SMX-R — Responder | 83 | 94 |
| LFU: TMP-SMX-R — Non-Responder | 88 | 89 |
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure (defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted); Failure, including clinical relapse (defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI); or Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT: ESBL-Phenotype — Clinical Cure | 160 | 185 |
| EOT: ESBL-Phenotype — Clinical Failure | 0 | 5 |
| EOT: ESBL-Phenotype — Clinical Indeterminate | 1 | 0 |
| EOT: FQ-NS — Clinical Cure | 196 | 206 |
| EOT: FQ-NS — Clinical Failure | 1 | 4 |
| EOT: FQ-NS — Clinical Indeterminate | 1 | 0 |
| EOT: TMP-SMX-R — Clinical Cure | 181 | 201 |
| EOT: TMP-SMX-R — Clinical Failure | 1 | 2 |
| EOT: TMP-SMX-R — Clinical Indeterminate | 0 | 0 |
| TOC: ESBL-Phenotype — Clinical Cure | 149 | 183 |
| TOC: ESBL-Phenotype — Clinical Failure | 9 | 5 |
| TOC: ESBL-Phenotype — Clinical Indeterminate | 3 | 2 |
| TOC: FQ-NS — Clinical Cure | 183 | 201 |
| TOC: FQ-NS — Clinical Failure | 11 | 5 |
| TOC: FQ-NS — Clinical Indeterminate | 4 | 4 |
| TOC: TMP-SMX-R — Clinical Cure | 175 | 196 |
| TOC: TMP-SMX-R — Clinical Failure | 6 | 3 |
| TOC: TMP-SMX-R — Clinical Indeterminate | 1 | 4 |
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure (defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted); Failure, including clinical relapse (defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI); or Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| LFU: ESBL-Phenotype — Cure, Including Sustained Clinical Cure | 143 | 175 |
| LFU: ESBL-Phenotype — Failure, Including Clinical Relapse or Indeterminate | 18 | 15 |
| LFU: FQ-NS — Cure, Including Sustained Clinical Cure | 173 | 191 |
| LFU: FQ-NS — Failure, Including Clinical Relapse or Indeterminate | 25 | 19 |
| LFU: TMP-SMX-R — Cure, Including Sustained Clinical Cure | 166 | 189 |
| LFU: TMP-SMX-R — Failure, Including Clinical Relapse or Indeterminate | 16 | 14 |
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure: Sustained clinical cure is defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted; Failure, including clinical relapse: Clinical relapse is defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI; Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT: ESBL-Phenotype — Clinical Cure | 157 | 176 |
| EOT: ESBL-Phenotype — Clinical Failure | 0 | 3 |
| EOT: FQ-NS — Clinical Cure | 191 | 200 |
| EOT: FQ-NS — Clinical Failure | 0 | 3 |
| EOT: TMP-SMX-R — Clinical Cure | 177 | 194 |
| EOT: TMP-SMX-R — Clinical Failure | 0 | 2 |
| TOC: ESBL-Phenotype — Clinical Cure | 143 | 176 |
| TOC: ESBL-Phenotype — Clinical Failure | 9 | 1 |
| TOC: FQ-NS — Clinical Cure | 176 | 197 |
| TOC: FQ-NS — Clinical Failure | 10 | 2 |
| TOC: TMP-SMX-R — Clinical Cure | 167 | 188 |
| TOC: TMP-SMX-R — Clinical Failure | 5 | 1 |
| LFU: ESBL-Phenotype — Clinical Cure | 137 | 164 |
| LFU: ESBL-Phenotype — Clinical Failure | 14 | 8 |
| LFU: FQ-NS — Clinical Cure | 167 | 179 |
| LFU: FQ-NS — Clinical Failure | 19 | 13 |
| LFU: TMP-SMX-R — Clinical Cure | 158 | 173 |
| LFU: TMP-SMX-R — Clinical Failure | 13 | 10 |
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, including sustained microbiologic eradication, i.e.,microbiologic eradication at TOC and no subsequent urine culture after TOC demonstrating recurrence of original Baseline uropathogen at ≥10\^3 CFU/mL;Persistence, including microbiologic recurrence, i.e.,isolation from urine culture at ≥10\^3 CFU/mL or blood culture of any of Baseline uropathogen(s) at any time after documented eradication at TOC visit up to and including LFU visit; Microbiologic indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. If a participant is assessed as a microbiological persistence at EOT, participant is automatically considered persistent at TOC and LFU. If assessed as persistent at TOC, participant is automatically considered a persistent at LFU.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT: ESBL-Phenotype — Microbiologic Eradication | 156 | 177 |
| EOT: ESBL-Phenotype — Microbiologic Persistence | 1 | 2 |
| EOT: ESBL-Phenotype — Microbiologic Indeterminate | 4 | 11 |
| EOT: FQ-NS — Microbiologic Eradication | 190 | 201 |
| EOT: FQ-NS — Microbiologic Persistence | 1 | 2 |
| EOT: FQ-NS — Microbiologic Indeterminate | 7 | 7 |
| EOT: TMP-SMX-R — Microbiologic Eradication | 178 | 193 |
| EOT: TMP-SMX-R — Microbiologic Persistence | 0 | 3 |
| EOT: TMP-SMX-R — Microbiologic Indeterminate | 4 | 7 |
| TOC: ESBL-Phenotype — Microbiologic Eradication | 88 | 108 |
| TOC: ESBL-Phenotype — Microbiologic Persistence | 67 | 72 |
| TOC: ESBL-Phenotype — Microbiologic Indeterminate | 6 | 10 |
| TOC: FQ-NS — Microbiologic Eradication | 102 | 119 |
| TOC: FQ-NS — Microbiologic Persistence | 87 | 82 |
| TOC: FQ-NS — Microbiologic Indeterminate | 9 | 9 |
| TOC: TMP-SMX-R — Microbiologic Eradication | 104 | 114 |
| TOC: TMP-SMX-R — Microbiologic Persistence | 72 | 79 |
| TOC: TMP-SMX-R — Microbiologic Indeterminate | 6 | 10 |
Participants were evaluated for clinical response outcome based on assessment of signs and symptoms as: Cure, including sustained clinical cure: Sustained clinical cure is defined as met criteria for clinical cure at TOC, and remained free of new or recurrent signs and symptoms of cUTI or AP at LFU visit such that no further antibacterial therapy is warranted; Failure, including clinical relapse: Clinical relapse is defined as met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at LFU visit and participant requires antibacterial therapy for cUTI; Clinical indeterminate: insufficient data are available to determine if participant is a sustained clinical cure or clinical relapse. If a participant is assessed as a clinical failure at EOT, participant is automatically considered a failure at TOC and LFU visits. If a participant is assessed as a clinical failure at TOC, participant is automatically considered a failure at LFU visit.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| LFU: ESBL-Phenotype — Eradication, Including Sustained Microbiologic Eradication | 72 | 102 |
| LFU: ESBL-Phenotype — Persistence, Including Microbiologic Recurrence or Indeterminate | 89 | 88 |
| LFU: FQ-NS — Eradication, Including Sustained Microbiologic Eradication | 83 | 110 |
| LFU: FQ-NS — Persistence, Including Microbiologic Recurrence or Indeterminate | 115 | 100 |
| LFU: TMP-SMX-R — Eradication, Including Sustained Microbiologic Eradication | 87 | 105 |
| LFU: TMP-SMX-R — Persistence, Including Microbiologic Recurrence or Indeterminate | 95 | 98 |
Participants were evaluated for microbiological response based on blood and urine cultures as: Eradication, including sustained microbiologic eradication, i.e.,microbiologic eradication at TOC and no subsequent urine culture after TOC demonstrating recurrence of original Baseline uropathogen at ≥10\^3 CFU/mL;Persistence, including microbiologic recurrence, i.e.,isolation from urine culture at ≥10\^3 CFU/mL or blood culture of any of Baseline uropathogen(s) at any time after documented eradication at TOC visit up to and including LFU visit; Microbiologic indeterminate: no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. If a participant is assessed as a microbiological persistence at EOT, participant is automatically considered persistent at TOC and LFU. If assessed as persistent at TOC, participant is automatically considered a persistent at LFU.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| EOT: ESBL-Phenotype — Microbiologic Eradication | 156 | 177 |
| EOT: ESBL-Phenotype — Microbiologic Persistence | 1 | 2 |
| EOT: FQ-NS — Microbiologic Eradication | 190 | 201 |
| EOT: FQ-NS — Microbiologic Persistence | 1 | 2 |
| EOT: TMP-SMX-R — Microbiologic Eradication | 177 | 193 |
| EOT: TMP-SMX-R — Microbiologic Persistence | 0 | 3 |
| TOC: ESBL-Phenotype — Microbiologic Eradication | 87 | 106 |
| TOC: ESBL-Phenotype — Microbiologic Persistence | 65 | 71 |
| TOC: FQ-NS — Microbiologic Eradication | 100 | 117 |
| TOC: FQ-NS — Microbiologic Persistence | 86 | 82 |
| TOC: TMP-SMX-R — Microbiologic Eradication | 102 | 112 |
| TOC: TMP-SMX-R — Microbiologic Persistence | 70 | 77 |
Participants will be evaluated for microbiological response based on blood and urine cultures as :Eradication, including sustained microbiologic eradication, i.e., microbiologic eradication at TOC and no subsequent urine culture after TOC demonstrating recurrence of original Baseline uropathogen at ≥10\^3 CFU/mL;Persistence, including microbiologic recurrence, i.e.,isolation from urine culture at ≥10\^3 CFU/mL or blood culture of any of Baseline uropathogen(s) at any time after documented eradication at TOC visit up to and including LFU visit; Microbiologic indeterminate:no follow-up urine culture is available, or urine culture results are missing, or follow-up urine culture cannot be interpreted for any reason. If a participant is assessed as a microbiological persistence at EOT,participant is automatically considered persistent at TOC and LFU. If assessed as persistent at TOC, participant is automatically considered a persistent at LFU.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| LFU: ESBL-Phenotype — Eradication, Including Sustained Microbiologic Eradication | 70 | 96 |
| LFU: ESBL-Phenotype — Persistence, Including Microbiologic Recurrence | 81 | 76 |
| LFU: FQ-NS — Eradication, Including Sustained Microbiologic Eradication | 82 | 102 |
| LFU: FQ-NS — Persistence, Including Microbiologic Recurrence | 104 | 90 |
| LFU: TMP-SMX-R — Eradication, Including Sustained Microbiologic Eradication | 85 | 98 |
| LFU: TMP-SMX-R — Persistence, Including Microbiologic Recurrence | 86 | 85 |
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal investigational/experimental) product, whether or not related to this product. Serious Adverse Event (SAE) is any AE occurring at any dose and regardless of causality that results in death, is life threatening, requires immediate or prolongation of hospitalization, results in significant disability, congenital anomaly and is a medically important reaction. TEAEs are defined as events that are newly occurring or worsening from the time of the first dose of IP through LFU.
| Participants | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| TEAEs | 235 | 201 |
| Serious TEAEs | 29 | 22 |
| nanograms per milliliter | TBP-PI-HBr 600 mg | TBP-PI-HBr 300 mg |
|---|---|---|
| 0.25-hour Post | 3834 ± 394 | 793 ± 7341 |
| 0.5-hour Post | 3836 ± 387 | 791 ± 7327 |
| 1.0-hour Post | 4678 ± 258 | 7374 ± 16 |
| 1.5-hour Post | 3933 ± 147 | 6890 ± 30 |
| 2-hour Post | 2982 ± 156 | 4042 ± 42 |
| 4-hour Post | 1247 ± 144 | 2163 ± 43 |
| 6-hour Post | 654 ± 234 | 1313 ± 29 |
Collected over From first dose of study drug (Day 1) up to last follow-up visit (Day 28). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TBP-PI-HBr | 2/843 (0.2%) | 29/843 (3.4%) | 68/843 (8.1%) |
| Imipenem-cilastatin | 2/844 (0.2%) | 22/844 (2.6%) | 23/844 (2.7%) |
| Event | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| Urinary tract infectionInfections and infestations | 6/843 | 3/844 |
| PneumoniaInfections and infestations | 0/843 | 3/844 |
| Pyelonephritis acuteInfections and infestations | 2/843 | 0/844 |
| Cardiac failureCardiac disorders | 0/843 | 2/844 |
| Clostridium difficile colitisInfections and infestations | 0/843 | 2/844 |
| Gastrointestinal inflammationGastrointestinal disorders | 1/843 | 0/844 |
| DeathGeneral disorders | 1/843 | 0/844 |
| Anal abscessInfections and infestations | 1/843 | 0/844 |
| COVID-19Infections and infestations | 1/843 | 0/844 |
| CystitisInfections and infestations | 1/843 | 0/844 |
| Event | TBP-PI-HBr | Imipenem-cilastatin |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 68/843 | 23/844 |
The safety population includes randomized participants who received any amount of the study drug or comparator.
| Age, Continuous(years) | TBP-PI-HBr | Imipenem-cilastatin | Total |
|---|---|---|---|
| Mean | 63.8 ± 15.13 | 63.4 ± 15.28 | 63.6 ± 15.20 |
| Sex: Female, Male(Participants) | TBP-PI-HBr | Imipenem-cilastatin | Total |
|---|---|---|---|
| Female | 437 | 478 | 915 |
| Male | 406 | 366 | 772 |
| Ethnicity (NIH/OMB)(Participants) | TBP-PI-HBr | Imipenem-cilastatin | Total |
|---|---|---|---|
| Hispanic or Latino | 38 | 47 | 85 |
| Not Hispanic or Latino | 805 | 797 | 1602 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | TBP-PI-HBr | Imipenem-cilastatin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 29 | 25 | 54 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 17 | 36 |
| White | 794 | 801 | 1595 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2023 to primary completion in Jan 2025, 13 months.
Results were first posted in Mar 2026, 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 13 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 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tebipenem