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

Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study.

Sponsors

Lead Sponsor: Pfizer

Source 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.

Overall Status Completed
Start Date January 2002
Completion Date June 2006
Primary Completion Date June 2006
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
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
Enrollment 160
Condition
Intervention

Intervention Type: Drug

Intervention Name: Meropenem

Eligibility

Criteria:

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:

-

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD Study Director AstraZeneca
Location
Facility:
Research Site | Baja, Hungary
Research Site | Budapest, Hungary
Research Site | Eger, Hungary
Research Site | Kecskemet, Hungary
Research Site | Kistarcsa, Hungary
Research Site | Miskolc, Hungary
Research Site | Pecs, Hungary
Research Site | Siofok, Hungary
Research Site | Szekesfehervar, Hungary
Research Site | Szolnok, Hungary
Research Site | Szombathely, Hungary
Research Site | Veszprem, Hungary
Location Countries

Hungary

Verification Date

August 2017

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov