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

Condition(s) targeted: Sepsis

Intervention: Meropenem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD, Study Director, Affiliation: AstraZeneca

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

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:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

-

Research Site, Budapest, Hungary

Research Site, Baja, 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

Starting date: March 2002
Ending date: December 2006
Last updated: January 11, 2008