Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00318552
Previous Study | Return to List | Next Study

Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00318552
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : September 1, 2017
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 25, 2006
First Posted Date  ICMJE April 27, 2006
Last Update Posted Date September 1, 2017
Study Start Date  ICMJE January 2002
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
  • Number of days from randomization to recovery from sepsis among those patients who survived the trial period
  • Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
  • Number of days from randomization to ready to discharge from the ICU
  • Number of days from randomization until patient is discharged from the ICU
  • Number of days on first line antibiotic therapy
  • Number of days from randomization until patient is discharged from hospital
  • Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy
  • Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy
  • Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group
  • Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
  • Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
Official Title  ICMJE Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.
Brief Summary This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sepsis
Intervention  ICMJE Drug: Meropenem
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE
 (submitted: April 26, 2006)
160
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00318552
Other Study ID Numbers  ICMJE 3591/9014
D9211C09014 ( Other Identifier: AZ IMPACT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD AstraZeneca
PRS Account Pfizer
Verification Date August 2017

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