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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00318552

Purpose

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.

Condition	Intervention	Phase
Sepsis	Drug: Meropenem	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis

Drug Information available for: Meropenem

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	160
Study Start Date:	March 2002
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318552

Locations

Hungary
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
Veszprem, Hungary
Research Site
Siofok, Hungary
Research Site
Szekesfehervar, Hungary
Research Site
Szolnok, Hungary
Research Site
Szombathely, Hungary
Research Site
Pecs, Hungary

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	3591/9014, D9211C09014
Study First Received:	April 25, 2006
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00318552 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:

Antibiotic Therapy
sepsis treatment
Meropenem

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Anti-Bacterial Agents
Sepsis
Pathologic Processes
Shock

Therapeutic Uses
Meropenem
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010