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 bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.

Condition	Intervention	Phase
Community-Acquired Infections	Drug: Azithromycin microspheres 2.0 single dose	Phase III

Further Study Details: 

Primary Outcomes: To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.
Secondary Outcomes: To assess bacteriological efficacy of 2.0 g single dose of azithromycin microspheres. To assess the safety and tolerability of 2.0 g single dose of azithromycin microspheres.
Expected Total Enrollment:  50

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 Criteria:

• Known or suscepted 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00140023

Study chairs or principal investigators

Pfizer Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A0661149
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00140023
Health Authority: Philippines : Department of Health
ClinicalTrials.gov processed this record on 2005-09-06