Status:
COMPLETED
Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation
Lead Sponsor:
PETHEMA Foundation
Conditions:
Allogenic Blood Stem Cell Transplantation
Febrile Neutropenia
Eligibility:
All Genders
18+ years
Brief Summary
Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT00462878
Start Date
November 1 2002
End Date
April 1 2009
Last Update
May 12 2009
Active Locations (64)
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1
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, Spain
2
Hospital U. Germans Trias i Pujol
Badalona, Barcelona, Spain
3
Hospital C. de Barcelona
Barcelona, Barcelona, Spain
4
Hospital del Mar
Barcelona, Barcelona, Spain