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

Primary Purpose

Pneumonia, Bacterial

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ampicillin sodium/sulbactam sodium
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Bacterial focused on measuring ampicillin sodium/sulbactam sodium, Unasyn-S, community acquired pneumonia, bacterial pneumonia

Eligibility Criteria

16 Years - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tosei General Hospital
  • National Hospital Organization Kokura Medical Center
  • University of Occupational and Environmental Health
  • Nagata Hospital
  • National Hospital Organization Asahikawa Medical Center
  • National Hokkaido Medical Center
  • National Hospital Organization Himeji Medical Center
  • KKR Takamatsu Hospital
  • Nippon Koukan Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • National Hospital Organization Kumamoto Saishyunsou Hospital
  • Saka General Hospital/Respiratory
  • National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital
  • Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
  • Nagasaki University School of Medicine
  • National Hospital Organization Minami-Okayama Medical Center
  • National Hospital Organization Ureshino Medical Center
  • Sekishinkai Sayama Hospital
  • National Hospital Organization Tenryu National Hospital
  • Fukuoka Sanno Hospital
  • National Hospital Organization Kochi National Hospital
  • Saiseikai Kumamoto Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ampicillin sodium/sulbactam sodium

Arm Description

ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Response Rate (Clinical Response, Investigator 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.
The Tendency Toward Clinical Improvement (Investigator Assessment)
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)
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)
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.

Full Information

First Posted
August 16, 2010
Last Updated
July 9, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01189487
Brief Title
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial
Keywords
ampicillin sodium/sulbactam sodium, Unasyn-S, community acquired pneumonia, bacterial pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ampicillin sodium/sulbactam sodium
Arm Type
Experimental
Arm Description
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
Intervention Type
Drug
Intervention Name(s)
ampicillin sodium/sulbactam sodium
Other Intervention Name(s)
Unasyn-S
Intervention Description
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Primary Outcome Measure Information:
Title
Response Rate (Clinical Response, Data Review Committee Assessment)
Description
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.
Time Frame
End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Secondary Outcome Measure Information:
Title
Response Rate (Clinical Response, Investigator Assessment)
Description
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.
Time Frame
End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Title
The Tendency Toward Clinical Improvement (Investigator Assessment)
Description
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.
Time Frame
Day 4
Title
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Description
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.
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)
Title
Eradication Rate (Bacteriological Response, Investigator Assessment)
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Tosei General Hospital
City
Seto-shi
State/Province
Aichi-ken
Country
Japan
Facility Name
National Hospital Organization Kokura Medical Center
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
University of Occupational and Environmental Health
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Nagata Hospital
City
Yanagawa
State/Province
Fukuoka
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
National Hokkaido Medical Center
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Himejishi
State/Province
Hyogo
Country
Japan
Facility Name
KKR Takamatsu Hospital
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
Nippon Koukan Hospital
City
Kawasaki-city
State/Province
Kanagawa
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
National Hospital Organization Kumamoto Saishyunsou Hospital
City
Koushi-shi
State/Province
Kumamoto
Country
Japan
Facility Name
Saka General Hospital/Respiratory
City
Shiogama
State/Province
Miyagi
Country
Japan
Facility Name
National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
City
Isahaya
State/Province
Nagasaki
Country
Japan
Facility Name
Nagasaki University School of Medicine
City
Nagasaki-city
State/Province
Nagasaki
Country
Japan
Facility Name
National Hospital Organization Minami-Okayama Medical Center
City
Tsukubo-gun
State/Province
Okayama
Country
Japan
Facility Name
National Hospital Organization Ureshino Medical Center
City
Ureshino-shi
State/Province
Saga
Country
Japan
Facility Name
Sekishinkai Sayama Hospital
City
Sayama
State/Province
Saitama
Country
Japan
Facility Name
National Hospital Organization Tenryu National Hospital
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Fukuoka Sanno Hospital
City
Fukuoka
Country
Japan
Facility Name
National Hospital Organization Kochi National Hospital
City
Kochi
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25533886
Citation
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.
Results Reference
derived
PubMed Identifier
24102758
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9231001&StudyName=The%20Study%20of%20Unasyn-S%2012g/day%20for%20Community%20Acquired%20Pneumonia%20%28CAP%29
Description
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The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

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