A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Paratek Pharmaceuticals Inc
- Enrollment
- 735
- Locations
- 50
- Primary Endpoint
- Number of Participants With Early Clinical Response
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients, ages 18 years or older who have signed the informed consent
- •Has a qualifying skin and skin structure infection
- •Female patients 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
- •Infections where the outcome is strongly influenced by factors other than protocol-defined treatments and procedures, or that require antibacterial treatment for greater than 14 days
- •Evidence of significant immunological disease
- •Severe renal disease or requirement for dialysis
- •Evidence of septic shock
- •Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
- •Has received an investigational drug within the past 30 days
- •Women who are pregnant or nursing
Arms & Interventions
Omadacycline
Omadacycline tablets
Intervention: Omadacycline (Drug)
Linezolid
Linezolid tablets
Intervention: Linezolid (Drug)
Outcomes
Primary Outcomes
Number of Participants With Early Clinical Response
Time Frame: Screening; 48 to 72 hours after the first dose of test article
Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason.
Secondary Outcomes
- Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit(Screening; 7 to 14 days after the last day of therapy)
- Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population(Screening; 7 to 14 days after the last day of therapy)