Clinical trial NCT00318552: Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Keywords: Antibiotic Therapy
sepsis treatment
Meropenem
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

-

Primary outcomes:
measure: Number of days from randomization to recovery from sepsis among those patients who survived the trial period
measure: Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis
Secondary outcomes:
measure: Number of days from randomization to ready to discharge from the ICU
measure: Number of days from randomization until patient is discharged from the ICU
measure: Number of days on first line antibiotic therapy
measure: Number of days from randomization until patient is discharged from hospital
measure: Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy
measure: Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy
measure: Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group
measure: Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
measure: Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials
Other outcomes:
Locations:
city: Baja
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Kistarcsa
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Siofok
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD
role: STUDY_DIRECTOR
References: