The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Bacterial
Intervention: ampicillin sodium/sulbactam sodium (Drug)
Phase: Phase 3
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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 in Japan. The purpose of this trial is to evaluate the clinical
efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving
ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
Official title: A Multicenter, Unblinded, Non-Comparative Study Of Unasyn-S 12 G/Day Evaluating The Safety And Efficacy In Japanese Adult Subjects With Community Acquired Pneumonia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response Rate (Clinical Response, Data Review Committee Assessment)
Response Rate (Clinical Response, Investigator Assessment)
The Tendency Toward Clinical Improvement (Investigator Assessment)
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Eradication Rate (Bacteriological Response, Investigator Assessment)
Minimum age: 16 Years.
Maximum age: 79 Years.
- 16 years of age or older.
- Patients who were diagnosed as moderate to severe community acquired pneumonia
requiring initial intravenous therapy and hospitalization.
- 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.
Locations and Contacts
Fukuoka Sanno Hospital, Fukuoka, Japan
National Hospital Organization Kochi National Hospital, Kochi, Japan
Saiseikai Kumamoto Hospital, Kumamoto, Japan
Tosei General Hospital, Seto-shi, Aichi-ken, Japan
National Hospital Organization Kokura Medical Center, Kitakyushu, Fukuoka, Japan
University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan
Nagata Hospital, Yanagawa, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center, Asahikawa, Hokkaido, Japan
National Hokkaido Medical Center, Sapporo, Hokkaido, Japan
National Hospital Organization Himeji Medical Center, Himejishi, Hyogo, Japan
KKR Takamatsu Hospital, Takamatsu, Kagawa, Japan
Nippon Koukan Hospital, Kawasaki-city, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center, Yokohama, Kanagawa, Japan
National Hospital Organization Kumamoto Saishyunsou Hospital, Koushi-shi, Kumamoto, Japan
Saka General Hospital/Respiratory, Shiogama, Miyagi, Japan
National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital, Matsumoto, Nagano, Japan
Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Isahaya, Nagasaki, Japan
Nagasaki University School of Medicine, Nagasaki-city, Nagasaki, Japan
National Hospital Organization Minami-Okayama Medical Center, Tsukubo-gun, Okayama, Japan
National Hospital Organization Ureshino Medical Center, Ureshino-shi, Saga, Japan
Sekishinkai Sayama Hospital, Sayama, Saitama, Japan
National Hospital Organization Tenryu National Hospital, Hamamatsu, Shizuoka, Japan
To obtain contact information for a study center near you, click here.
Starting date: October 2010
Last updated: July 9, 2012