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

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00462878
First received: April 18, 2007
Last updated: May 11, 2009
Last verified: May 2009
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: April 18, 2007
Last Updated: May 11, 2009
Health Authority: Spain: Spanish Ministry of Health

Keywords provided by PETHEMA Foundation:
Febrile neutropenia

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

ClinicalTrials.gov processed this record on July 22, 2014