Official Title: “A Multi-Center, Open Label Study to Evaluate the Efficacy and Safety of Azithromycin Microspheres in Subjects Identified as Having Low Risk Community Acquired Pneumonia (CAP)”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Azithromycin microspheres 2.0 single dose

Primary Measures

• To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.

Secondary Measures

• 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.

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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00140023

Study ID Number: A0661149

ClinicalTrials.gov Identifier: NCT00140023

Health Authority: Philippines: Bureau of Food and Drugs

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting