Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation
- Conditions
- Allogenic Blood Stem Cell TransplantationFebrile Neutropenia
- Registration Number
- NCT00462878
- Lead Sponsor
- PETHEMA Foundation
- 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 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (64)
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Balears, Spain
Hospital U. Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital General de Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital Niño Jesus
🇪🇸Sabadell, Barcelona, Spain
Hospital Mutua Tarrasa
🇪🇸Terrassa, Barcelona, Spain
Hospital Insular de Las Palmas
🇪🇸Las palmas de Gran Canaria, Canarias, Spain
Hospital Materno-Infantil de Las Palmas
🇪🇸Las Palmas de Gran Canaria, Canarias, Spain
Hospital Ntra Sra del Pino/Sabinal
🇪🇸las Palmas de Gran Canaria, Canarias, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Canarias, Spain
Scroll for more (54 remaining)Hospital Central de Asturias🇪🇸Oviedo, Asturias, Spain