The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
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
1 other identifier
interventional
47
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2010
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 26, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
May 18, 2012
CompletedJuly 13, 2012
July 1, 2012
6 months
August 16, 2010
April 19, 2012
July 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (4)
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)
The Tendency Toward Clinical Improvement (Investigator Assessment)
Day 4
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 (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)
Study Arms (1)
ampicillin sodium/sulbactam sodium
EXPERIMENTALampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
Interventions
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Eligibility Criteria
You may qualify if:
- years of age or older.
- Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (22)
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
Related Publications (2)
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.
PMID: 25533886DERIVEDSoto 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.
PMID: 24102758DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2010
First Posted
August 26, 2010
Study Start
October 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
July 13, 2012
Results First Posted
May 18, 2012
Record last verified: 2012-07