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

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ClinicalTrials.gov Identifier: NCT01189487
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : May 18, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 16, 2010
First Posted Date  ICMJE August 26, 2010
Results First Submitted Date  ICMJE April 19, 2012
Results First Posted Date  ICMJE May 18, 2012
Last Update Posted Date July 13, 2012
Study Start Date  ICMJE October 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
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) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
  • The clinical efficacy assessed by Data Review Committee [ Time Frame: Test of Cure (TOC); treatment period is 3 days (min) to 14 days (max) depending on pneumonia state. ]
  • The clinical efficacy assessed by Data Review Committee [ Time Frame: 7 days after End of Treatment (EOT) ]
Change History Complete list of historical versions of study NCT01189487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2012)
  • 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) ]
    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 ]
    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) ]
    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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
  • The clinical efficacy assessed by Data Review Committee [ Time Frame: at End of Treatment (EOT); 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The clinical efficacy assessed by Data Review Committee [ Time Frame: Long Term Follow up (LTFU); 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The clinical efficacy assessed by Data Review Committee [ Time Frame: 7 days after TOC; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The clinical efficacy assessed by Investigator [ Time Frame: at EOT; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The clinical efficacy assessed by Investigator [ Time Frame: TOC; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The clinical efficacy assessed by Investigator [ Time Frame: LTFU; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The tendency toward clinical improvement assessed by Investigator [ Time Frame: at Day 4 ]
  • The bacteriological efficacy assessed by Data Review Committee [ Time Frame: at Day 4 ]
  • The bacteriological efficacy assessed by Data Review Committee [ Time Frame: EOT; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The bacteriological efficacy assessed by Data Review Committee [ Time Frame: TOC; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The bacteriological efficacy assessed by Data Review Committee [ Time Frame: LTFU; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The bacteriological efficacy assessed by Investigator [ Time Frame: at Day 4 ]
  • The bacteriological efficacy assessed by Investigator [ Time Frame: EOT; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The bacteriological efficacy assessed by Investigator [ Time Frame: TOC; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • The bacteriological efficacy assessed by Investigator [ Time Frame: LTFU; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • Safety; AEs, laboratory test values and vital sign [ Time Frame: until LTFU; 3 days (min) up to 14 days (max) depending on pneumonia state. ]
  • PPK analysis [ Time Frame: during treatment period 3 days (min) up to 14 days (max) depending on pneumonia state. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia, Bacterial
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
Intervention: Drug: ampicillin sodium/sulbactam sodium
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2011)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2010)
45
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189487
Other Study ID Numbers  ICMJE A9231001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP