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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: 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) ]

Original Primary Outcome:

• 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) ]

Current Secondary Outcome:

• 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:

• 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. ]

Dates:
Date Received: August 16, 2010
Date Started: October 2010
Date Completion:
Last Updated: July 9, 2012
Last Verified: July 2012