Status:
COMPLETED
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
Lead Sponsor:
Paratek Pharmaceuticals Inc
Conditions:
Uncomplicated Urinary Tract Infection
Cystitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2019
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT03425396
Start Date
January 4 2018
End Date
June 5 2019
Last Update
June 9 2020
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 106
Chula Vista, California, United States, 91911
2
Site 101
La Mesa, California, United States, 91942
3
Site 109
Los Angeles, California, United States, 90017
4
Site 114
Aventura, Florida, United States, 33180