Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

• Status: Completed
• Trial end date: 2019-06-05
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paratek Pharmaceuticals Inc
• Treatments: Nitrofurantoin

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