Back to resultsAzithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
Primary Purpose
Community-Acquired Pneumonia
Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Azithromycin microspheres 2.0 single dose
Sponsored by
About this trial
This is an interventional treatment trial for Community-Acquired Pneumonia
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00140023
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Azithromycin microspheres 2.0 single dose
Primary Outcome Measure Information:
Title
To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Mandaluyong City
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Manila
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Muntinlupa City
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon City
Country
Philippines
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661149&StudyName=Azithromycin+Microspheres+in+Patients+with+Low+Risk+Community+Acquired+Pneumonia+
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
We'll reach out to this number within 24 hrs