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| Sponsored by: |
Wyeth |
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00079885 |
Purpose
To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.
| Condition | Intervention | Phase |
|
Community Acquired Pneumonia Bacterial Pneumonia Cross Infection |
Drug: tigecycline |
Phase III |
| MedlinePlus related topics: | Pneumonia |
| Drug Information available for: | Tigecycline Levofloxacin Ofloxacin Ofloxacin hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Safety/Efficacy Study |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 3074A1-308 |
| First Received: | March 18, 2004 |
| Last Updated: | October 9, 2007 |
| ClinicalTrials.gov Identifier: | NCT00079885 |
| Health Authority: | United States: Food and Drug Administration |
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