The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
NCT ID: NCT01189487
Last Updated: 2012-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
47 participants
INTERVENTIONAL
2010-10-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Interventions
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ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.
Exclusion Criteria
* 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.
16 Years
79 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Tosei General Hospital
Seto-shi, Aichi-ken, Japan
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, 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, Hyōgo, Japan
KKR Takamatsu Hospital
Takamatsu, Kagawa-ken, Japan
Nippon Koukan Hospital
Kawasaki, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan
National Hospital Organization Kochi National Hospital
Kochi, Kochi, Japan
National Hospital Organization Kumamoto Saishyunsou Hospital
Koushi-shi, Kumamoto, Japan
Saiseikai Kumamoto Hospital
Kumamoto, 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, Nagasaki, Japan
National Hospital Organization Minami-Okayama Medical Center
Tsukubo-gun, Okayama-ken, Japan
National Hospital Organization Ureshino Medical Center
Ureshino-shi, Saga-ken, Japan
Sekishinkai Sayama Hospital
Sayama, Saitama, Japan
National Hospital Organization Tenryu National Hospital
Hamamatsu, Shizuoka, Japan
Countries
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References
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Kohno S, Tateda K, Mikamo H, Kadota J, Niki Y, Itamura R. Efficacy and safety of intravenous sulbactam/ampicillin 3 g 4 times daily in Japanese adults with moderate to severe community-acquired pneumonia: a multicenter, open-label, uncontrolled study. J Infect Chemother. 2015 Mar;21(3):182-8. doi: 10.1016/j.jiac.2014.11.006. Epub 2014 Nov 20.
Soto E, Shoji S, Muto C, Tomono Y, Marshall S. Population pharmacokinetics of ampicillin and sulbactam in patients with community-acquired pneumonia: evaluation of the impact of renal impairment. Br J Clin Pharmacol. 2014 Mar;77(3):509-21. doi: 10.1111/bcp.12232.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A9231001
Identifier Type: -
Identifier Source: org_study_id