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

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

MedlinePlus related topics:

Antibiotics Sepsis

ChemIDplus related topics:

Meropenem

U.S. FDA Resources

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.

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:	December 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

Study ID Numbers:	3591/9014, D9211C09014
First Received:	April 25, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00318552
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:

Antibiotic Therapy

sepsis treatment

Meropenem

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome

Sepsis

Shock

Meropenem

Neoplasm Metastasis

Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Pathologic Processes

Therapeutic Uses

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

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