Phase 2
Completed N=201
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
Acute Pyelonephritis
Source: ClinicalTrials.gov NCT03757234 ↗
Enrolled (actual)
201
Serious AEs
3.0%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) — 68; 15; 15; 16 Participants
Summary
The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis.
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) |
68; 15; 15; 16; 69; 5 | — |
| PRIMARY Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population) |
32; 3; 9; 5; 39; 13 | — |
| PRIMARY Number of Participants With Resolution of All AP Signs and Clinical Symptoms at PTE Visit (ITT Population) |
51; 15; 14; 13; 54 | — |
| PRIMARY Number of Participants With No Worsening and Absence of New AP Signs and Clinical Symptoms at PTE Visit (ITT Population) |
62; 16; 16; 15; 65 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events |
23; 6; 9; 8; 24; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Female participants, age 18-65 years who have signed the informed consent form
- Must have a qualifying acute pyelonephritis
- 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
- Must be able to comply with all of the requirements of the study
Exclusion Criteria
- Males
- Symptoms of acute pyelonephritis present for longer 7 days prior to randomization
- Infections that require antibacterial treatment for greater than 14 days
- Evidence of suspected non-renal source of infections, vaginitis, or sexually transmitted infection
- Evidence of significant immunological disease
- Evidence of liver impairment or disease
- Evidence of unstable cardiac disease
- Severe renal disease or requirement for dialysis
- Evidence of septic shock
- Has a history of hypersensitivity or allergic reaction to any tetracycline or to levofloxacin
- Has received an investigational drug within the past 30 days
- Participants who are pregnant or nursing
- Unable or unwilling to comply with the protocol requirements
Data sourced from ClinicalTrials.gov (NCT03757234). 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. Informational only — not medical advice.