Clinical trial NCT03425396: Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
Official title: A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of Oral Omadacycline and Oral Nitrofurantoin in the Treatment of Female Adults With Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Urinary Tract Infection
Cystitis
Lead sponsor: Paratek Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
timeFrame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Secondary outcomes:
measure: Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population)
timeFrame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population)
timeFrame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population)
timeFrame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population)
timeFrame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population)
timeFrame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population)
timeFrame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population)
timeFrame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
measure: Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population)
timeFrame: FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
measure: Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population)
timeFrame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
measure: Number of Participants With a Microbiological Response at the EOT Visit (ME-EOT Population)
timeFrame: EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
measure: Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population)
timeFrame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
measure: Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population)
timeFrame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Other outcomes:
measure: Number of Participants With Resolution of All Urinary Tract Infection (UTI) Signs and Clinical Symptoms at PTE Visit (ITT Population)
timeFrame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
measure: Number of Participants With No Worsening and Absence of New UTI Signs and Clinical Symptoms at PTE Visit (ITT Population)
timeFrame: Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Locations:
city: Chula Vista
country: United States
facility: Site 106
state: California
city: La Mesa
country: United States
facility: Site 101
state: California
city: Los Angeles
country: United States
facility: Site 109
state: California
city: Aventura
country: United States
facility: Site 114
state: Florida
city: DeLand
country: United States
facility: Site 102
state: Florida
city: Hialeah
country: United States
facility: Site 103
state: Florida
city: Jacksonville
country: United States
facility: Site 125
state: Florida
city: Miami Springs
country: United States
facility: Site 127
state: Florida
city: Miami
country: United States
facility: Site 121
state: Florida
city: Miami
country: United States
facility: Site 130
state: Florida
city: Miami
country: United States
facility: Site 115
state: Florida
city: Orlando
country: United States
facility: Site 126
state: Florida
city: Newton
country: United States
facility: Site 113
state: Kansas
city: Wichita
country: United States
facility: Site 110
state: Kansas
city: Omaha
country: United States
facility: Site 112
state: Nebraska
city: Las Vegas
country: United States
facility: Site 132
state: Nevada
city: Las Vegas
country: United States
facility: Site 108
state: Nevada
city: Berlin
country: United States
facility: Site 122
state: New Jersey
city: Raleigh
country: United States
facility: Site 118
state: North Carolina
city: Jackson
country: United States
facility: Site 104
state: Tennessee
city: Smyrna
country: United States
facility: Site 105
state: Tennessee
city: Houston
country: United States
facility: Site 131
state: Texas
city: San Antonio
country: United States
facility: Site 120
state: Texas
Study officials:
References: