The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
- Registration Number
- NCT01189487
- Lead Sponsor
- Pfizer
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ampicillin sodium/sulbactam sodium ampicillin sodium/sulbactam sodium ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
- Primary Outcome Measures
Name Time Method Response Rate (Clinical Response, Data Review Committee Assessment) End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
- Secondary Outcome Measures
Name Time Method Response Rate (Clinical Response, Investigator Assessment) End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants EXCLUDING ones assessed as indeterminate" multiplied by 100.
The Tendency Toward Clinical Improvement (Investigator Assessment) Day 4 The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment.
Eradication Rate (Bacteriological Response, Data Review Committee Assessment) Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication, presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment.
Eradication Rate (Bacteriological Response, Investigator Assessment) Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment.
Trial Locations
- Locations (22)
Tosei General Hospital
🇯🇵Seto-shi, Aichi-ken, Japan
Nagata Hospital
🇯🇵Yanagawa, Fukuoka, Japan
University of Occupational and Environmental Health
🇯🇵Kitakyushu, Fukuoka, Japan
National Hospital Organization Himeji Medical Center
🇯🇵Himejishi, Hyogo, Japan
Nagasaki University School of Medicine
🇯🇵Nagasaki-city, Nagasaki, Japan
National Hokkaido Medical Center
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Kokura Medical Center
🇯🇵Kitakyushu, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center
🇯🇵Asahikawa, Hokkaido, Japan
National Hospital Organization Kumamoto Saishyunsou Hospital
🇯🇵Koushi-shi, Kumamoto, Japan
KKR Takamatsu Hospital
🇯🇵Takamatsu, Kagawa, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Yokohama, Kanagawa, Japan
Nippon Koukan Hospital
🇯🇵Kawasaki-city, Kanagawa, Japan
Saka General Hospital/Respiratory
🇯🇵Shiogama, Miyagi, Japan
National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital
🇯🇵Matsumoto, Nagano, Japan
National Hospital Organization Ureshino Medical Center
🇯🇵Ureshino-shi, Saga, Japan
Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
🇯🇵Isahaya, Nagasaki, Japan
National Hospital Organization Minami-Okayama Medical Center
🇯🇵Tsukubo-gun, Okayama, Japan
Sekishinkai Sayama Hospital
🇯🇵Sayama, Saitama, Japan
National Hospital Organization Tenryu National Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Fukuoka Sanno Hospital
🇯🇵Fukuoka, Japan
National Hospital Organization Kochi National Hospital
🇯🇵Kochi, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto, Japan