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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

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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)

Secondary outcome:

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)

Eligibility

Minimum age: 16 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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.

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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2010
Last updated: July 9, 2012

Page last updated: August 23, 2015

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