Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2019 |
| Start Date: | June 2015 |
| End Date: | May 2016 |
A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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.
to linezolid in the treatment of adults with acute bacterial skin and skin structure
infections.
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
We found this trial at
19
sites
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