The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

Pneumonia, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189487
• Other study ID #: A9231001
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2010
• Last updated: July 9, 2012
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 79 Years

Eligibility

Inclusion Criteria:

• 16 years of age or older.

• Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.

Exclusion Criteria:

• 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days

Locations

Country	Name	City	State
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa	Hokkaido
Japan	Fukuoka Sanno Hospital	Fukuoka
Japan	National Hospital Organization Tenryu National Hospital	Hamamatsu	Shizuoka
Japan	National Hospital Organization Himeji Medical Center	Himejishi	Hyogo
Japan	Japanese Red Cross Nagasaki Genbaku Isahaya Hospital	Isahaya	Nagasaki
Japan	Nippon Koukan Hospital	Kawasaki-city	Kanagawa
Japan	National Hospital Organization Kokura Medical Center	Kitakyushu	Fukuoka
Japan	University of Occupational and Environmental Health	Kitakyushu	Fukuoka
Japan	National Hospital Organization Kochi National Hospital	Kochi
Japan	National Hospital Organization Kumamoto Saishyunsou Hospital	Koushi-shi	Kumamoto
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital	Matsumoto	Nagano
Japan	Nagasaki University School of Medicine	Nagasaki-city	Nagasaki
Japan	National Hokkaido Medical Center	Sapporo	Hokkaido
Japan	Sekishinkai Sayama Hospital	Sayama	Saitama
Japan	Tosei General Hospital	Seto-shi	Aichi-ken
Japan	Saka General Hospital/Respiratory	Shiogama	Miyagi
Japan	KKR Takamatsu Hospital	Takamatsu	Kagawa
Japan	National Hospital Organization Minami-Okayama Medical Center	Tsukubo-gun	Okayama
Japan	National Hospital Organization Ureshino Medical Center	Ureshino-shi	Saga
Japan	Nagata Hospital	Yanagawa	Fukuoka
Japan	Kanagawa Cardiovascular and Respiratory Center	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate (Clinical Response, Data Review Committee Assessment)	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.	End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)	No
Secondary	Response Rate (Clinical Response, Investigator Assessment)	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.	End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)	No
Secondary	The Tendency Toward Clinical Improvement (Investigator Assessment)	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.	Day 4	No
Secondary	Eradication Rate (Bacteriological Response, Data Review Committee Assessment)	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.	Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)	No
Secondary	Eradication Rate (Bacteriological Response, Investigator Assessment)	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.	Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)	No

External Links

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