Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
Phase 4
Completed
- Conditions
- Sepsis
- Registration Number
- NCT00318552
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials Number of days from randomization until patient is discharged from hospital Number of days on 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 Number of days from randomization to ready to discharge from the ICU Number of days from randomization until patient is discharged from the ICU Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
Trial Locations
- Locations (1)
Research Site
🇭🇺Veszprem, Hungary