Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paratek Pharmaceuticals Inc
• Treatments: Linezolid

Criteria

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 treatment and procedures, that require antibacterial treatment for greater than 14 days

• Evidence of significant immunological disease

• Severe sepsis or septic shock

• Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid

• Has received an investigational drug within past 30 days

• Women who are pregnant or nursing