Status:
COMPLETED
Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Community Acquired Pneumonia
Bacterial Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Male and female subjects ≥ 18 years of ag.
- Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated
- The presence of fever (within 24 hours prior to randomization), defined as oral temperature \>38°C/100.4°F, axillary temperature \>38.1°C/100.6°F, tympanic temperature \>38.5°C/ 101.2°F, or a rectal/core temperature \>39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature \<35°C/95°
Exclusion
- 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 prior to the onset of symptoms
- Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00079885
Start Date
November 1 2003
End Date
July 1 2005
Last Update
February 8 2013
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