NCT00081575CompletedPhase 3
A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
Wyeth is now a wholly owned subsidiary of Pfizer0 sites434 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 434
- Primary Endpoint
- Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
Study Overview
Brief Summary
To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female subjects ≥ 18 years of age and in Bulgaria only ≤ 70 years of age
- •Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment for at least 7 days
- •The presence of fever (within 24 hours before randomization)
Exclusion Criteria
- •Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy <30 days).
- •Hospitalization within 14 days before the onset of symptoms.
- •Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms.
Outcomes
Primary Outcomes
Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
Determine whether tigecycline is noninferior to levofloxacin.
Secondary Outcomes
No secondary outcomes reported
Investigators
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