A Phase 2 interventional study of Omadacycline tablets and Nitrofurantoin capsules in Uncomplicated Urinary Tract Infection and Cystitis, sponsored by Paratek Pharmaceuticals Inc. Completed at 23 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Paratek Pharmaceuticals Inc · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as compared to oral nitrofurantoin in the treatment of female adults with cystitis.
Participants were randomized to receive 7 days of treatment of either omadacycline or nitrofurantoin. The End of Treatment visit, Post Therapy Evaluation visit, and Final Follow-up visit was planned within 2 days following the last dose of study drug, on Day 14 (+/- 2 days) after the first dose of study drug, and within 30 to 37 days following the first dose of study drug, respectively. The study followed a double-dummy design. To maintain the study blinding, participants assigned to omadacycline received active omadacycline tablets and over-encapsulated nitrofurantoin placebo tablets. Participants assigned to the nitrofurantoin arm received omadacycline placebo tablets and over-encapsulated active nitrofurantoin capsules.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's enrollment of 225 is above the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →Paratek Pharmaceuticals Inc is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
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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.
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Drug: Omadacycline tablets
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Drug: Omadacycline tablets
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Drug: Omadacycline tablets
Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Drug: Omadacycline tablets
Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.
Drug: Nitrofurantoin capsules
Oral Omadacycline
Oral Nitrofurantoin
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population)
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the EOT visit was not completed.
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population)
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the EOT visit was not completed.
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population)
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure or indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population)
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the FFU visit was not completed
Time frame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population)
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
Time frame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population)
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the FFU visit was not completed.
Time frame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population)
Microbiological response was determined programmatically at the EOT visit by assessing whether or not the participant met the microbiological outcome of Favorable, Unfavorable, or Indeterminate. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. The microbiological outcome was deemed as Indeterminate when the urine specimen was not available to culture or the culture result was not interpretable.
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With a Microbiological Response at the EOT Visit (ME-EOT Population)
Microbiological response was determined programmatically at the EOT visit by assessing whether or not the participant met the microbiological outcome of Favorable or Unfavorable. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. For the ME population, the microbiological outcome was not deemed as indeterminate response.
Time frame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of Favorable, Unfavorable, or Indeterminate. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. The microbiological outcome was deemed as Indeterminate when the urine specimen was not available to culture or the culture result was not interpretable.
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population)
Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of Favorable or Unfavorable. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. For the ME population, the microbiological outcome was not deemed as indeterminate response.
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With Resolution of All Urinary Tract Infection (UTI) Signs and Clinical Symptoms at PTE Visit (ITT Population)
Participants recorded their assessments using the UTI Symptoms Assessment (UTISA) questionnaire, a 14-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for seven UTI signs and symptoms: Frequency, Urgency, Pain/burning on urination, Incomplete voiding, Pain in pelvic area, Low back pain, and Blood in urine. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 7 items, divided by the number of non-missing items, and then multiplied by 7. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 21 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With No Worsening and Absence of New UTI Signs and Clinical Symptoms at PTE Visit (ITT Population)
Participants recorded their assessments using the UTI Symptoms Assessment (UTISA) questionnaire, a 14-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for seven UTI signs and symptoms: Frequency, Urgency, Pain/burning on urination, Incomplete voiding, Pain in pelvic area, Low back pain, and Blood in urine. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 7 items, divided by the number of non-missing items, and then multiplied by 7. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 21 (worst severity/most bothersome). Number of participants with no worsening and absence of new UTI signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.
Time frame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
| Milestone | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Started | 55 | 54 | 54 | 8 | 54 |
| Completed end of treatment visit | 53 | 52 | 51 | 7 | 53 |
| Completed post-therapy evaluation visit | 53 | 49 | 51 | 7 | 54 |
| Completed final follow-up visit | 53 | 47 | 51 | 7 | 53 |
| Completed | 53 | 47 | 51 | 7 | 53 |
| Not completed | 2 | 7 | 3 | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 5 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Other | 0 | 1 | 1 | 0 | 1 |
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical Success | 48 | 42 | 46 | 7 | 49 |
| Clinical Failure | 5 | 6 | 5 | 0 | 5 |
| Indeterminate | 2 | 6 | 3 | 1 | 0 |
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the EOT visit was not completed.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical Success | 49 | 47 | 49 | 7 | 49 |
| Clinical Failure | 4 | 5 | 2 | 0 | 4 |
| Indeterminate | 2 | 2 | 3 | 1 | 1 |
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the EOT visit was not completed.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical Success | 22 | 29 | 22 | 5 | 27 |
| Clinical Failure | 1 | 4 | 1 | 0 | 3 |
| Indeterminate | 2 | 1 | 0 | 0 | 0 |
Clinical response was determined by the investigator at the EOT visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the EOT visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the EOT visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical Success | 47 | 42 | 47 | 7 | 48 |
| Clinical Failure | 3 | 5 | 0 | 0 | 4 |
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical success | 45 | 41 | 46 | 7 | 45 |
| Clinical failure | 4 | 5 | 1 | 0 | 4 |
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure or indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical success | 21 | 27 | 21 | 5 | 27 |
| Clinical failure | 2 | 5 | 2 | 0 | 3 |
| Indeterminate | 2 | 2 | 0 | 0 | 0 |
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the FFU visit was not completed
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical success | 47 | 41 | 44 | 7 | 49 |
| Clinical failure | 6 | 7 | 7 | 0 | 5 |
| Indeterminate | 2 | 6 | 3 | 1 | 0 |
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success or Clinical Failure. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. For the CE population, the clinical outcome was not deemed as indeterminate response.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical success | 43 | 37 | 39 | 7 | 45 |
| Clinical failure | 4 | 6 | 4 | 0 | 4 |
Clinical response was determined by the investigator at the FFU visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the FFU visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection at the FFU visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the FFU visit was not completed.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Clinical success | 21 | 26 | 20 | 5 | 27 |
| Clinical failure | 2 | 6 | 3 | 0 | 3 |
| Indeterminate | 2 | 2 | 0 | 0 | 0 |
Microbiological response was determined programmatically at the EOT visit by assessing whether or not the participant met the microbiological outcome of Favorable, Unfavorable, or Indeterminate. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. The microbiological outcome was deemed as Indeterminate when the urine specimen was not available to culture or the culture result was not interpretable.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Favorable | 18 | 27 | 17 | 5 | 28 |
| Unfavorable | 5 | 6 | 6 | 0 | 1 |
| Indeterminate | 2 | 1 | 0 | 0 | 1 |
Microbiological response was determined programmatically at the EOT visit by assessing whether or not the participant met the microbiological outcome of Favorable or Unfavorable. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. For the ME population, the microbiological outcome was not deemed as indeterminate response.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Favorable | 18 | 25 | 16 | 5 | 28 |
| Unfavorable | 4 | 6 | 6 | 0 | 1 |
Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of Favorable, Unfavorable, or Indeterminate. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. The microbiological outcome was deemed as Indeterminate when the urine specimen was not available to culture or the culture result was not interpretable.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Favorable | 14 | 20 | 15 | 4 | 23 |
| Unfavorable | 8 | 11 | 8 | 1 | 6 |
| Indeterminate | 3 | 3 | 0 | 0 | 1 |
Microbiological response was determined programmatically at the PTE visit by assessing whether or not the participant met the microbiological outcome of Favorable or Unfavorable. Favorable microbiological outcomes included eradication and presumed eradication i.e., urine specimen showed absence of the original baseline pathogen or the baseline pathogen grew at \<10\^4 CFU/mL at visit. Unfavorable microbiological outcome included persistence i.e. urine culture showed continued presence (defined as ≥10\^4 CFU/mL) of the original baseline pathogen(s) at visit. For the ME population, the microbiological outcome was not deemed as indeterminate response.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Favorable | 13 | 20 | 14 | 4 | 22 |
| Unfavorable | 7 | 9 | 7 | 1 | 6 |
Participants recorded their assessments using the UTI Symptoms Assessment (UTISA) questionnaire, a 14-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for seven UTI signs and symptoms: Frequency, Urgency, Pain/burning on urination, Incomplete voiding, Pain in pelvic area, Low back pain, and Blood in urine. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 7 items, divided by the number of non-missing items, and then multiplied by 7. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 21 (worst severity/most bothersome). Number of participants with resolution of all symptoms, without occurrence of new symptoms is reported. Resolution was defined as absence of all baseline symptoms.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Number of Participants With Resolution of All Urinary Tract Infection (UTI) Signs and Clinical Symptoms at PTE Visit (ITT Population) | 33 | 30 | 32 | 6 | 34 |
Participants recorded their assessments using the UTI Symptoms Assessment (UTISA) questionnaire, a 14-item questionnaire that assessed the levels of 'severity' and 'bothersomeness' for seven UTI signs and symptoms: Frequency, Urgency, Pain/burning on urination, Incomplete voiding, Pain in pelvic area, Low back pain, and Blood in urine. The sub-scale responses were recorded as 'did not have', 'mild', 'moderate', and 'severe' for 'severity'; and 'not at all', 'a little', 'moderately', and 'a lot' for 'bothersomeness', both scored 0-3. Total scores were calculated by summing the non-missing scores of the 7 items, divided by the number of non-missing items, and then multiplied by 7. For each sub-scale, the total score ranged from 0 (least Severe/ least bothersome) and 21 (worst severity/most bothersome). Number of participants with no worsening and absence of new UTI signs and clinical symptoms is reported. No worsening meant that each question score is same or better at post baseline.
| Participants | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Number of Participants With No Worsening and Absence of New UTI Signs and Clinical Symptoms at PTE Visit (ITT Population) | 50 | 45 | 45 | 7 | 50 |
Collected over Up to approximately 37 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omadacycline 300/300 Once Every 24 Hours | 0/55 (0%) | 0/55 (0%) | 16/55 (29.1%) |
| Omadacycline 450/300 Once Every 24 Hours | 0/54 (0%) | 0/54 (0%) | 13/54 (24.1%) |
| Omadacycline 450/450 Once Every 24 Hours | 0/54 (0%) | 1/54 (1.9%) | 15/54 (27.8%) |
| Omadacycline 450/450 Once Every 12 Hours | 0/8 (0%) | 0/8 (0%) | 4/8 (50%) |
| Nitrofurantoin 100/100 Once Every 12 Hours | 0/54 (0%) | 0/54 (0%) | 9/54 (16.7%) |
| Event | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| Pyelonephritis AcuteInfections and infestations | 0/55 | 0/54 | 1/54 | 0/8 | 0/54 |
| Event | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 12/55 | 8/54 | 10/54 | 4/8 | 5/54 |
| HeadacheNervous system disorders | 3/55 | 2/54 | 4/54 | 2/8 | 1/54 |
| Abdominal discomfortGastrointestinal disorders | 0/55 | 0/54 | 0/54 | 1/8 | 0/54 |
| VomitingGastrointestinal disorders | 3/55 | 3/54 | 3/54 | 1/8 | 0/54 |
| HordeolumInfections and infestations | 0/55 | 0/54 | 0/54 | 1/8 | 0/54 |
| DysgeusiaNervous system disorders | 0/55 | 0/54 | 0/54 | 1/8 | 0/54 |
| DiarrhoeaGastrointestinal disorders | 2/55 | 1/54 | 3/54 | 0/8 | 2/54 |
| Asymptomatic bacteriuriaInfections and infestations | 1/55 | 2/54 | 1/54 | 0/8 | 0/54 |
| BronchitisInfections and infestations | 0/55 | 0/54 | 0/54 | 0/8 | 2/54 |
| Urinary tract infectionInfections and infestations | 1/55 | 1/54 | 2/54 | 0/8 | 0/54 |
The Intent-to-Treat (ITT) Population consisted of all randomized participants regardless of whether or not the participant received study drug.
| Age, Continuous(years) | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours | Total |
|---|---|---|---|---|---|---|
| Mean | 45.3 ± 17.05 | 47.4 ± 15.70 | 45.0 ± 15.49 | 37.5 ± 13.60 | 45.5 ± 17.82 | 45.5 ± 16.41 |
| Sex: Female, Male(Participants) | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours | Total |
|---|---|---|---|---|---|---|
| Female | 55 | 54 | 54 | 8 | 54 | 225 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 47 | 47 | 43 | 7 | 47 | 191 |
| Not Hispanic or Latino | 8 | 7 | 11 | 1 | 7 | 34 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Omadacycline 300/300 Once Every 24 Hours | Omadacycline 450/300 Once Every 24 Hours | Omadacycline 450/450 Once Every 24 Hours | Omadacycline 450/450 Once Every 12 Hours | Nitrofurantoin 100/100 Once Every 12 Hours | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 1 |
| Asian | 0 | 1 | 1 | 0 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 | 2 |
| Black or African American | 2 | 1 | 4 | 2 | 4 | 13 |
| White | 52 | 52 | 48 | 6 | 47 | 205 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in May 2019, 16 months.
Results were first posted in Jun 2020, 1 year after primary completion.
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Studies of the drug tested here: Omadacycline
Paratek Pharmaceuticals Inc