Status:
COMPLETED
Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
Lead Sponsor:
Pfizer
Conditions:
Community-Acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for ...
Eligibility Criteria
Inclusion
- Male or female, 18 years age or older, for whom oral, outpatient therapy is indicated.
- Diagnosis of CAP as manifested by at least 3 or more of the following:
- cough, pleuritic chest pain, fever (temperature of \>37.8 C to \<40 C), auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral white blood count (WBC\> 10,000/mm3 or greater than 15% immature neutrophils (bands)
Exclusion
- Known or suspected hypersensitivity or intolerance to azithromycin or other macrolides.
- Previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count \< 1,000/mm3, HIV positive subjects with CD4 count \< 200 cells/mm3, any immunoglobin or neutrophil disorder.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00140023
Start Date
September 1 2005
End Date
June 1 2006
Last Update
May 10 2011
Active Locations (5)
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1
Pfizer Investigational Site
Manila, National Capital Region, Philippines, 1000
2
Pfizer Investigational Site
City of Muntinlupa, Philippines
3
Pfizer Investigational Site
Mandaluyong, Philippines
4
Pfizer Investigational Site
Manila, Philippines