Phase 2
N=225
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
Uncomplicated Urinary Tract Infection · Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT03425396 ↗Enrolled (actual)
225
Serious AEs
0.4%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) — 48; 42; 46; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omadacycline tablets (Drug); Nitrofurantoin capsules (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Paratek Pharmaceuticals Inc
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) |
48; 42; 46; 7; 49; 5 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population) |
49; 47; 49; 7; 49; 4 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population) |
22; 29; 22; 5; 27; 1 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population) |
47; 42; 47; 7; 48; 3 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population) |
45; 41; 46; 7; 45; 4 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population) |
21; 27; 21; 5; 27; 2 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population) |
47; 41; 44; 7; 49; 6 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population) |
43; 37; 39; 7; 45; 4 | — |
| SECONDARY Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population) |
21; 26; 20; 5; 27; 2 | — |
| SECONDARY Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population) |
18; 27; 17; 5; 28; 5 | — |
| SECONDARY Number of Participants With a Microbiological Response at the EOT Visit (ME-EOT Population) |
18; 25; 16; 5; 28; 4 | — |
| SECONDARY Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population) |
14; 20; 15; 4; 23; 8 | — |
| SECONDARY Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population) |
13; 20; 14; 4; 22; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Female participants, age 18 or older who have signed the informed consent form
- Must have a qualifying uncomplicated urinary tract infection
- Participants must not be pregnant at the time of enrollment
- Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Exclusion Criteria
- Males
- Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or sexually transmitted infection
- Evidence of significant immunological disease
- Has received an investigational drug within the past 30 days
- Participants who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03425396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.