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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: August 16, 2010
• First Posted Date: August 26, 2010
• Results First Submitted Date: April 19, 2012
• Results First Posted Date: May 18, 2012
• Last Update Posted Date: July 13, 2012
• Study Start Date: October 2010
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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) ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pneumonia, Bacterial

Intervention

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

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 *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 2, 2011): 47
• Original Estimated Enrollment (submitted: August 25, 2010): 45
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 79 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01189487
• Other Study ID Numbers: A9231001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer
• Original Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2012