Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Paratek

Status and phase: Completed; Phase 3

Conditions: Skin Structures and Soft Tissue Infections; Bacterial Infections

Treatments: Drug: Omadacycline; Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02877927

PTK0796-ABSI-16301

Details and patient eligibility

About

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.

Enrollment: 735 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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735 participants in 2 patient groups

Omadacycline

Experimental group

Description:

Omadacycline tablets

Treatment:

Drug: Omadacycline

Linezolid

Active Comparator group

Description:

Linezolid tablets

Treatment:

Drug: Linezolid