Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community-Acquired Pneumonia
Intervention: Azithromycin microspheres 2.0 single dose (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the clinical efficacy of 2.0 g single dose of azithromycin microspheres in Low Risk CAP.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Quezon City, Philippines
Pfizer Investigational Site, Muntinlupa City, Philippines
Pfizer Investigational Site, Manila, Philippines
Pfizer Investigational Site, Mandaluyong City, Philippines
Pfizer Investigational Site, MANILA, Metro Manila 1000, Philippines
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Starting date: September 2005
Ending date: June 2006
Last updated: January 24, 2008
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