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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00318552
First received: April 25, 2006
Last updated: January 25, 2011
Last verified: January 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hungary
Research Site
Baja, Hungary
Research Site
Budapest, 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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00318552     History of Changes
Other Study ID Numbers: 3591/9014, D9211C09014
Study First Received: April 25, 2006
Last Updated: January 25, 2011
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:
Antibiotic Therapy
sepsis treatment
Meropenem

Additional relevant MeSH terms:
Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock
Anti-Bacterial Agents
Meropenem
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 22, 2014