Status:
COMPLETED
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Lead Sponsor:
Pfizer
Conditions:
Community Acquired Pneumonia (CAP)
Eligibility:
All Genders
16-80 years
Phase:
PHASE3
Brief Summary
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to ...
Eligibility Criteria
Inclusion
- 16 years of age or older patients with CAP.
- Patients who were diagnosed as moderate in severity.
Exclusion
- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
- Severe renal dysfunction (creatinine clearance \< 30 ml/min).
- Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
- Severe underlying disease.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00809328
Start Date
February 1 2009
End Date
March 1 2010
Last Update
May 19 2011
Active Locations (34)
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1
Pfizer Investigational Site
Seto-shi, Aichi-ken, Japan
2
Pfizer Investigational Site
Touon, Ehime, Japan
3
Pfizer Investigational Site
Chikushino-shi, Fukuoka, Japan
4
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan