Status:
COMPLETED
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
Lead Sponsor:
Paratek Pharmaceuticals Inc
Conditions:
Acute Pyelonephritis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief 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 ac...
Detailed Description
This was a randomized (1:1:1:1:1), double-blind, double-dummy, adaptive designed, Phase 2 study. Based on review of the efficacy and microbiology data, the DMC modified the randomization algorithm, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2019
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03757234
Start Date
November 19 2018
End Date
July 24 2019
Last Update
July 7 2020
Active Locations (31)
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1
Site 201
Tbilisi, Georgia
2
Site 202
Tbilisi, Georgia
3
Site 203
Tbilisi, Georgia
4
Site 204
Tbilisi, Georgia