Status:
COMPLETED
A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
Lead Sponsor:
Pfizer
Conditions:
Pneumonia, Community-Acquired
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.
Eligibility Criteria
Inclusion
- Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000)".
Exclusion
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. ("Severe" assessed by the Severity of underlying diseases and complications of "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft)" by the Japan Society of Chemotherapy (1997)).
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00360295
Start Date
September 1 2006
End Date
May 1 2007
Last Update
May 20 2008
Active Locations (54)
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1
Pfizer Investigational Site
Asahi, Chiba, Japan, 289-2511
2
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan, 810-0053
3
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan, 813-0031
4
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan, 813-0034