Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

• ClinicalTrials.gov Identifier: NCT00140023
• Recruitment Status: Completed
• First Posted: August 31, 2005
• Last Update Posted: May 10, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: August 29, 2005
• First Posted Date: August 31, 2005
• Last Update Posted Date: May 10, 2011
• Study Start Date: September 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: August 30, 2005): To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00140023 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: August 30, 2005): 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.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
• 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)
• 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 bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Community-Acquired Pneumonia
• Intervention: Drug: Azithromycin microspheres 2.0 single dose
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 9, 2011): 47
• Original Enrollment (submitted: August 30, 2005): 50
• Actual Study Completion Date: June 2006
• Primary Completion Date: Not Provided

Eligibility 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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Philippines

Administrative Information

• NCT Number: NCT00140023
• Other Study ID Numbers: A0661149
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2011