Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

Paratek

Status and phase: Completed; Phase 2

Conditions: Uncomplicated Urinary Tract Infection; Cystitis

Treatments: Drug: Nitrofurantoin capsules; Drug: Omadacycline tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT03425396

PTK0796-UUTI-17201

Details and patient eligibility

About

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.

Full 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 within 2 days following the last dose of study drug, on Day 14 (+/- 2 days) after the first dose of study drug, and within 30 to 37 days following the first dose of study drug, respectively. The study followed a double-dummy design. To maintain the study blinding, participants assigned to omadacycline received active omadacycline tablets and over-encapsulated nitrofurantoin placebo tablets. Participants assigned to the nitrofurantoin arm received omadacycline placebo tablets and over-encapsulated active nitrofurantoin capsules.

Enrollment: 225 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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225 participants in 5 patient groups

Omadacycline 300/300 once every 24 hours

Experimental group

Description:

Participants received omadacycline 300 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.

Treatment:

Drug: Omadacycline tablets

Omadacycline 450/300 once every 24 hours

Experimental group

Description:

Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 300 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.

Treatment:

Drug: Omadacycline tablets

Omadacycline 450/450 once every 24 hours

Experimental group

Description:

Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 24 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.

Treatment:

Drug: Omadacycline tablets

Omadacycline 450/450 once every 12 hours

Experimental group

Description:

Participants received omadacycline 450 milligrams orally, once every 12 hours, fed on Day 1 and omadacycline 450 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.

Treatment:

Drug: Omadacycline tablets

Nitrofurantoin 100/100 once every 12 hours

Active Comparator group

Description:

Participants received nitrofurantoin 100 milligrams orally, once every 12 hours, fed on Day 1 and nitrofurantoin 100 milligrams orally, once every 12 hours on Days 2 through 7. Odd doses on Days 2 to 7 were administered in a fasted state. Even doses on Days 2 to 7 were administered approximately 2 hours following a light meal.

Treatment:

Drug: Nitrofurantoin capsules