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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
April 18, 2007
April 19, 2007
May 12, 2009
November 2002
Not Provided
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Complete list of historical versions of study NCT00462878 on ClinicalTrials.gov Archive Site
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Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation
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
Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

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)

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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)
  • Allogenic Blood Stem Cell Transplantation
  • Febrile Neutropenia
  • Drug: Meropenem
    antibiotic
  • Drug: Vancomycin
    Antibiotic
  • Drug: Teicoplanin
    Antibiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
April 2009
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00462878
03-2002-GTA
Yes
Not Provided
Not Provided
Pethema
PETHEMA Foundation
Not Provided
Principal Investigator: Sanz Miguel Angel, Doctor Hospital La Fe
PETHEMA Foundation
May 2009