Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
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
1 other identifier
interventional
225
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2017
CompletedStudy Start
First participant enrolled
January 4, 2018
CompletedFirst Posted
Study publicly available on registry
February 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2019
CompletedResults Posted
Study results publicly available
June 4, 2020
CompletedJune 9, 2020
June 1, 2020
1.4 years
December 28, 2017
May 15, 2020
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population)
Clinical response was determined by the investigator at the PTE visit by assessing whether or not the participant met the clinical outcome of Clinical Success, Clinical Failure, or Indeterminate. Clinical Success was defined as sufficient resolution of cystitis signs and symptoms at the PTE visit such that no additional systemic antimicrobial therapy was required for the current infection. Clinical Failure was defined as no apparent response to therapy or persistence of signs and symptoms of infection or reappearance of signs and symptoms at or before the PTE visit such that use of additional systemic antimicrobial therapy for the current infection was required. The clinical outcome was deemed as Indeterminate when the PTE visit was not completed.
Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Secondary Outcomes (12)
Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population)
EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population)
EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population)
EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population)
Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population)
Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
- +7 more secondary outcomes
Other Outcomes (2)
Number of Participants With Resolution of All Urinary Tract Infection (UTI) Signs and Clinical Symptoms at PTE Visit (ITT Population)
Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Number of Participants With No Worsening and Absence of New UTI Signs and Clinical Symptoms at PTE Visit (ITT Population)
Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Study Arms (5)
Omadacycline 300/300 once every 24 hours
EXPERIMENTALParticipants 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.
Omadacycline 450/300 once every 24 hours
EXPERIMENTALParticipants 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.
Omadacycline 450/450 once every 24 hours
EXPERIMENTALParticipants 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.
Omadacycline 450/450 once every 12 hours
EXPERIMENTALParticipants 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.
Nitrofurantoin 100/100 once every 12 hours
ACTIVE COMPARATORParticipants 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.
Interventions
Oral Omadacycline
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Site 106
Chula Vista, California, 91911, United States
Site 101
La Mesa, California, 91942, United States
Site 109
Los Angeles, California, 90017, United States
Site 114
Aventura, Florida, 33180, United States
Site 102
DeLand, Florida, 32720, United States
Site 103
Hialeah, Florida, 33015, United States
Site 125
Jacksonville, Florida, 32256, United States
Site 121
Miami, Florida, 33126, United States
Site 130
Miami, Florida, 33126, United States
Site 115
Miami, Florida, 33134, United States
Site 127
Miami Springs, Florida, 33166, United States
Site 126
Orlando, Florida, 82306, United States
Site 113
Newton, Kansas, 67114, United States
Site 110
Wichita, Kansas, 67207, United States
Site 112
Omaha, Nebraska, 68144, United States
Site 132
Las Vegas, Nevada, 89106, United States
Site 108
Las Vegas, Nevada, 89109, United States
Site 122
Berlin, New Jersey, 08009, United States
Site 118
Raleigh, North Carolina, 27612, United States
Site 104
Jackson, Tennessee, 38305, United States
Site 105
Smyrna, Tennessee, 37167, United States
Site 131
Houston, Texas, 77061, United States
Site 120
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
An additional treatment group (omadacycline 450/450 once every 12 hours) was added with Protocol Amendment 2. However, the majority of enrollment was completed by this time, and therefore, fewer participants were enrolled in this group.
Results Point of Contact
- Title
- Paratek Medical Information
- Organization
- Paratek Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2017
First Posted
February 7, 2018
Study Start
January 4, 2018
Primary Completion
May 15, 2019
Study Completion
June 5, 2019
Last Updated
June 9, 2020
Results First Posted
June 4, 2020
Record last verified: 2020-06