Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)
Completed · Phase 3
Conditions studied: Bacterial Pneumonia, Community-Acquired Infections
In brief
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
Key facts
- Study ID
- NCT02531438
- Run by
- Paratek Pharmaceuticals Inc
- People needed
- 774
- Starts
- 2015-11-01
- Expected to finish
- 2017-03-10
- Last updated by the study team
- 2019-01-16
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 qualifying bacterial pneumonia
- 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…
- Known or suspected hospital-acquired pneumonia
- Evidence of significant immunological disease
- Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
- Has received an investigational drug within past 30 days
- Women who are pregnant or nursing
Where it is running
- Site 501 — Mobile, Alabama, United States
- Site 508 — Laguna Hills, California, United States
- Site 505 — Ventura, California, United States
- Site 513 — Stamford, Connecticut, United States
- Site 511 — Zachary, Louisiana, United States
- Site 503 — Detroit, Michigan, United States
- Site 520 — Saint Paul, Minnesota, United States
- Site 512 — St Louis, Missouri, United States
- Site 506 — Buffalo, New York, United States
- Site 509 — Dayton, Ohio, United States
- Site 516 — Huntington, West Virginia, United States
- Site 220 — Liège, Belgium
- Site 276 — Belo Horizonte, Minas Gerais, Brazil
- Site 277 — Passo Fundo, Rio Grande do Sul, Brazil
- Site 274 — Porto Alegre, Rio Grande do Sul, Brazil
- Site 279 — São José do Rio Preto, São Paulo, Brazil
- Site 305 — Kyustendil, Bulgaria
- Site 303 — Pernik, Bulgaria
- Site 304 — Plovdiv, Bulgaria
- Site 306 — Sliven, Bulgaria
- Site 301 — Sofia, Bulgaria
- Site 302 — Sofia, Bulgaria
- Site 307 — Sofia, Bulgaria
- Site 250 — Požega, Croatia
- Site 514 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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