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Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00140023
First received: August 29, 2005
Last updated: May 9, 2011
Last verified: May 2011
History of Changes

August 29, 2005
May 9, 2011
September 2005
Not Provided
To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.
Same as current
Complete list of historical versions of study NCT00140023 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Community-Acquired Pneumonia
Drug: Azithromycin microspheres 2.0 single dose
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
June 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00140023
A0661149
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP