Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

Completed · Phase 2

Conditions studied: Uncomplicated Urinary Tract Infection, Cystitis

In brief

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.

Key facts

Study ID

NCT03425396

Run by

Paratek Pharmaceuticals Inc

People needed

225

Starts

2018-01-04

Expected to finish

2019-06-05

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site 106 — Chula Vista, California, United States
• Site 101 — La Mesa, California, United States
• Site 109 — Los Angeles, California, United States
• Site 114 — Aventura, Florida, United States
• Site 102 — DeLand, Florida, United States
• Site 103 — Hialeah, Florida, United States
• Site 125 — Jacksonville, Florida, United States
• Site 121 — Miami, Florida, United States
• Site 130 — Miami, Florida, United States
• Site 115 — Miami, Florida, United States
• Site 127 — Miami Springs, Florida, United States
• Site 126 — Orlando, Florida, United States
• Site 113 — Newton, Kansas, United States
• Site 110 — Wichita, Kansas, United States
• Site 112 — Omaha, Nebraska, United States
• Site 132 — Las Vegas, Nevada, United States
• Site 108 — Las Vegas, Nevada, United States
• Site 122 — Berlin, New Jersey, United States
• Site 118 — Raleigh, North Carolina, United States
• Site 104 — Jackson, Tennessee, United States
• Site 105 — Smyrna, Tennessee, United States
• Site 131 — Houston, Texas, United States
• Site 120 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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