- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189487
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
July 9, 2012 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
- Fukuoka Sanno Hospital
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Kochi, Japan
- National Hospital Organization Kochi National Hospital
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Kumamoto, Japan
- Saiseikai Kumamoto Hospital
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Aichi-ken
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Seto-shi, Aichi-ken, Japan
- Tosei General Hospital
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Fukuoka
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Kitakyushu, Fukuoka, Japan
- National Hospital Organization Kokura Medical Center
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Kitakyushu, Fukuoka, Japan
- University of Occupational and Environmental Health
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Yanagawa, Fukuoka, Japan
- Nagata Hospital
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Hokkaido
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Asahikawa, Hokkaido, Japan
- National Hospital Organization Asahikawa Medical Center
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Sapporo, Hokkaido, Japan
- National Hokkaido Medical Center
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Hyogo
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Himejishi, Hyogo, Japan
- National Hospital Organization Himeji Medical Center
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Kagawa
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Takamatsu, Kagawa, Japan
- KKR Takamatsu Hospital
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Kanagawa
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Kawasaki-city, Kanagawa, Japan
- Nippon Koukan Hospital
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Yokohama, Kanagawa, Japan
- Kanagawa Cardiovascular and Respiratory Center
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Kumamoto
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Koushi-shi, Kumamoto, Japan
- National Hospital Organization Kumamoto Saishyunsou Hospital
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Miyagi
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Shiogama, Miyagi, Japan
- Saka General Hospital/Respiratory
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Nagano
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Matsumoto, Nagano, Japan
- National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital
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Nagasaki
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Isahaya, Nagasaki, Japan
- Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
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Nagasaki-city, Nagasaki, Japan
- Nagasaki University School of Medicine
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Okayama
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Tsukubo-gun, Okayama, Japan
- National Hospital Organization Minami-Okayama Medical Center
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Saga
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Ureshino-shi, Saga, Japan
- National Hospital Organization Ureshino Medical Center
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Saitama
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Sayama, Saitama, Japan
- Sekishinkai Sayama Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japan
- National Hospital Organization Tenryu National Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 79 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
|
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate (Clinical Response, Data Review Committee Assessment)
Time Frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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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.
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End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate (Clinical Response, Investigator Assessment)
Time Frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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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.
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End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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The Tendency Toward Clinical Improvement (Investigator Assessment)
Time Frame: Day 4
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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.
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Day 4
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Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Time Frame: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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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.
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Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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Eradication Rate (Bacteriological Response, Investigator Assessment)
Time Frame: 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.
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Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
August 16, 2010
First Submitted That Met QC Criteria
August 25, 2010
First Posted (Estimate)
August 26, 2010
Study Record Updates
Last Update Posted (Estimate)
July 13, 2012
Last Update Submitted That Met QC Criteria
July 9, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Pneumonia
- Pneumonia, Bacterial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- beta-Lactamase Inhibitors
- Ampicillin
- Sulbactam
Other Study ID Numbers
- A9231001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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