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

Sponsors

Lead Sponsor: Paratek Pharmaceuticals Inc

Source Paratek Pharmaceuticals Inc
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.

Overall Status Completed
Start Date January 4, 2018
Completion Date June 5, 2019
Primary Completion Date May 15, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Secondary Outcome
Measure Time Frame
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)
Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population) FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population) FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population) FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug)
Number of Participants With a Microbiological Response at the EOT Visit (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 a Microbiological Response at the EOT Visit (ME-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 a Microbiological 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)
Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population) Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug)
Enrollment 225
Condition
Intervention

Intervention Type: Drug

Intervention Name: Omadacycline tablets

Description: Oral Omadacycline

Intervention Type: Drug

Intervention Name: Nitrofurantoin capsules

Description: Oral Nitrofurantoin

Arm Group Label: Nitrofurantoin 100/100 once every 12 hours

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

Gender: Female

Gender Based: Yes

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
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 127 | Miami Springs, Florida, 33166, United States
Site 121 | Miami, Florida, 33126, United States
Site 130 | Miami, Florida, 33126, United States
Site 115 | Miami, Florida, 33134, 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
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Omadacycline 300/300 once every 24 hours

Type: Experimental

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.

Label: Omadacycline 450/300 once every 24 hours

Type: Experimental

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.

Label: Omadacycline 450/450 once every 24 hours

Type: Experimental

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.

Label: Omadacycline 450/450 once every 12 hours

Type: Experimental

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.

Label: Nitrofurantoin 100/100 once every 12 hours

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov