Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00140023

Purpose

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 Pneumonia	Drug: Azithromycin microspheres 2.0 single dose	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome 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.

Enrollment:	47
Study Start Date:	September 2005
Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140023

Locations

Philippines
Pfizer Investigational Site
Manila, Metro Manila, Philippines, 1000
Pfizer Investigational Site
Mandaluyong City, Philippines
Pfizer Investigational Site
Manila, Philippines
Pfizer Investigational Site
Muntinlupa City, Philippines
Pfizer Investigational Site
Quezon City, Philippines

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier:	NCT00140023 History of Changes
Other Study ID Numbers:	A0661149
Study First Received:	August 29, 2005
Last Updated:	May 9, 2011
Health Authority:	Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012