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

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ClinicalTrials.gov Identifier: NCT00318552
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : September 1, 2017
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Meropenem Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis
Drug Information available for: Meropenem
U.S. FDA Resources




Primary Outcome Measures :
  1. Number of days from randomization to recovery from sepsis among those patients who survived the trial period
  2. Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis

Secondary Outcome Measures :
  1. Number of days from randomization to ready to discharge from the ICU
  2. Number of days from randomization until patient is discharged from the ICU
  3. Number of days on first line antibiotic therapy
  4. Number of days from randomization until patient is discharged from hospital
  5. Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy
  6. Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy
  7. Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group
  8. Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group
  9. Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Pfizer
Investigators
Study Director: AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00318552     History of Changes
Other Study ID Numbers: 3591/9014
D9211C09014 ( Other Identifier: AZ IMPACT )
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by Pfizer:
Antibiotic Therapy
sepsis treatment
Meropenem

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