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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01189487
First received: August 16, 2010
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pneumonia, Bacterial
 Drug: ampicillin sodium/sulbactam sodium
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • The Tendency Toward Clinical Improvement (Investigator Assessment) [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 47
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
 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
Other Name: Unasyn-S

  Eligibility

Ages Eligible for Study:   16 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189487

Locations
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
Fukuoka Sanno Hospital
Fukuoka, Japan
National Hospital Organization Kochi National Hospital
Kochi, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01189487     History of Changes
Other Study ID Numbers: A9231001
Study First Received: August 16, 2010
Results First Received: April 19, 2012
Last Updated: July 9, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
ampicillin sodium/sulbactam sodium
Unasyn-S
community acquired pneumonia
bacterial pneumonia

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ampicillin
Sulbactam
 Sultamicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013