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

Pfizer160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Sepsis

Interventions

MeropenemDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (12)

Research Site

Baja, Hungary

Research Site

Budapest, Hungary

Research Site

Eger, Hungary

Research Site

Kecskemét, Hungary

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.