Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Phase 3

Completed

• Conditions: Bacterial Infections; Skin Structures and Soft Tissue Infections
• Interventions: Drug: Omadacycline; Drug: Linezolid

• Registration Number: NCT02877927
• Lead Sponsor: Paratek Pharmaceuticals Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Primary Completion: 2017-05-26
• Study Completion: 2017-06-06
• Disposition First Submitted: 2018-02-01
• Disposition First Submitted QC: 2018-02-01
• Disposition First Posted: 2018-02-05
• Status Verified: 2018-11
• Results First Submitted: 2018-11-02
• Results First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Results First Posted: 2018-11-30
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 735

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omadacycline	Omadacycline	Omadacycline tablets
Linezolid	Linezolid	Linezolid tablets

Primary Outcome Measures

Name	Time	Method
Number of Participants With Early Clinical Response	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 Outcome Measures

Name	Time	Method
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	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; infection was sufficiently resolved such that further antibacterial therapy was not needed. Participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the End-of-Treatment (EOT) Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation; other specified reason. Indeterminate The clinical response to test article could not be adequately inferred.
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	At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; infection was sufficiently resolved such that further antibacterial therapy was not needed. Participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the EOT Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation; other specified reason.

Trial Locations

Locations (50)

Site 620; 🇺🇸 Birmingham, Alabama, United States

Site 642; 🇺🇸 Mobile, Alabama, United States

Site 616; 🇺🇸 Anaheim, California, United States

Site 601; 🇺🇸 Anaheim, California, United States

Site 636; 🇺🇸 Bakersfield, California, United States

Site 606; 🇺🇸 Buena Park, California, United States

Site 604; 🇺🇸 Chula Vista, California, United States

Site 659; 🇺🇸 Huntington Beach, California, United States

Site 608; 🇺🇸 La Mesa, California, United States

Site 618; 🇺🇸 Laguna Hills, California, United States

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