Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
Completed · Phase 3
Conditions studied: Bacterial Infections, Skin Structures and Soft Tissue Infections
In brief
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.
Key facts
- Study ID
- NCT02378480
- Run by
- Paratek Pharmaceuticals Inc
- People needed
- 655
- Starts
- 2015-06-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2019-03-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Site 262 — Chula Vista, California, United States
- Site 254 — La Mesa, California, United States
- Site 258 — Oceanside, California, United States
- Site 252 — Santa Ana, California, United States
- Site 260 — Santa Ana, California, United States
- Site 269 — Stockton, California, United States
- Site 259 — Miami, Florida, United States
- Site 264 — West Palm Beach, Florida, United States
- Site 256 — Augusta, Georgia, United States
- Site 253 — Columbus, Georgia, United States
- Site 257 — Springfield, Massachusetts, United States
- Site 268 — Detroit, Michigan, United States
- Site 266 — Butte, Montana, United States
- Site 263 — Las Vegas, Nevada, United States
- Site 270 — Somers Point, New Jersey, United States
- Site 273 — Buffalo, New York, United States
- Site 255 — Rapid City, South Dakota, United States
- Site 104 — Pleven, Bulgaria
- Site 102 — Plovdiv, Bulgaria
- Site 105 — Plovdiv, Bulgaria
- Site 103 — Rousse, Bulgaria
- Site 101 — Sofia, Bulgaria
- Site 205 — Slavonski Brod, Croatia
- Site 201 — Zagreb, Croatia
- Site 261 — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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