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Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation (MERONEM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00462878
First Posted: April 19, 2007
Last Update Posted: May 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
PETHEMA Foundation
  Purpose
Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

Condition Intervention
Allogenic Blood Stem Cell Transplantation Febrile Neutropenia Drug: Meropenem Drug: Vancomycin Drug: Teicoplanin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MERONEM: Observational Study About Efficacy of Meropenem in Comparison of Meropenem and Glycopeptide in Treatment of Neutropenia Febrile in Allogenic Blood Stem Cell Transplantation Patients

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Estimated Enrollment: 392
Study Start Date: November 2002
Study Completion Date: April 2009
Intervention Details:
    Drug: Meropenem
    antibiotic
    Drug: Vancomycin
    Antibiotic
    Drug: Teicoplanin
    Antibiotic
Detailed Description:

Observational study cost-effectivity to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

The study will be done in two consecutive cohorts of patients. First cohort: meropenem 1g/8h ev Second cohort: meropenem 1g/8h and glycopeptide (vancomycin 1g/12 h or teicoplanin 400 mg/24h)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients submitted to allogenic transplant with neutropenia (neutrophils account < 500/mm3 or neutrophils account < 1000/mm3 with prevision to decrease until 500/mm3 at the next 24-48 h); Signs and symptoms to infection; Fever (Temperature> 38,3 ºC registered one time, or 38 ºC en two times separated 60 minutes in a period of 12 h)
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patients submitted to allogenic transplant
  • Neutropenia: neutrophils account < 500/mm3 or neutrophils account < 1000/mm3 with prevision to decrease until 500/mm3 at the next 24-48 h
  • Signs and symptoms to infection
  • Fever: Temperature> 38,3 ºC registered one time, or 38 ºC en two times separated 60 minutes in a period of 12 h.

Exclusion Criteria:

  • Medical history of meropenem or glycopeptides hypersensitivity
  • Renal failure or creatinine in serum > 2,25 mg/dl or creatinine clearance < 40 ml
  • Liver insufficiency
  • Childbearing potential or breast feeding period
  • Contraindications to meropenem, vancomycin or teicoplanin
  Contacts and Locations
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): NCT00462878


  Show 64 Study Locations
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Principal Investigator: Sanz Miguel Angel, Doctor Hospital La Fe
  More Information

Publications:

Responsible Party: Pethema
ClinicalTrials.gov Identifier: NCT00462878     History of Changes
Other Study ID Numbers: 03-2002-GTA
First Submitted: April 18, 2007
First Posted: April 19, 2007
Last Update Posted: May 12, 2009
Last Verified: May 2009

Keywords provided by PETHEMA Foundation:
Febrile neutropenia

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Vancomycin
Meropenem
Thienamycins
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents