Status:
COMPLETED
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Lead Sponsor:
Pfizer
Conditions:
Pneumonia, Bacterial
Eligibility:
All Genders
16-79 years
Phase:
PHASE3
Brief Summary
Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved...
Eligibility Criteria
Inclusion
- 16 years of age or older.
- Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.
Exclusion
- Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems.
- Hepatic dysfunction \[Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin \> 3 times upper limit of normal range values\].
- Severe renal dysfunction (creatinine clearance \< 30 ml/min).
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01189487
Start Date
October 1 2010
End Date
April 1 2011
Last Update
July 13 2012
Active Locations (22)
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1
Tosei General Hospital
Seto-shi, Aichi-ken, Japan
2
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
3
National Hospital Organization Kokura Medical Center
Kitakyushu, Fukuoka, Japan
4
University of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan