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 Universitario de Canarias
🇪🇸Tenerife, Canarias, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Verge de la Cinta
🇪🇸Tortosa, Tarragona, Spain
Hospital Virgen Blanca
🇪🇸Leon, León, Spain
Hospital U. Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital General de Manresa
🇪🇸Manresa, Barcelona, Spain
Hospital de Cruces
🇪🇸Bilbao, Spain
Hospital General de Castellón
🇪🇸Castellón, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Balears, Spain
Hospital G. de Alicante
🇪🇸Alicante, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital U. Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital Materno-Infantil de Las Palmas
🇪🇸Las Palmas de Gran Canaria, Canarias, Spain
Hospital Juan Canalejo
🇪🇸La Coruña, Spain
Hospital Francesc de Borja
🇪🇸Gandia, Spain
Hospital Virgen de Las Nieves
🇪🇸Granada, Spain
Basurtuko Ospitalea
🇪🇸Basurto, Spain
Hospital Durant y Reynals
🇪🇸Barcelona, Spain
Hospital Sant Pau
🇪🇸Barcelona, Spain
Hospital Insular de Las Palmas
🇪🇸Las palmas de Gran Canaria, Canarias, Spain
Hospital Principe de Asturias
🇪🇸Alcalá de Henares, Madrid, Spain
Hospital de Sagunto
🇪🇸Sagunto, Valencia, Spain
Hospital Luis Alcañiz de Xátiva
🇪🇸Xativa, Valencia, Spain
Hospital San Millan
🇪🇸Cáceres, Spain
H. Xeral de Galicia
🇪🇸La Coruña, Spain
Hospital Mutua Tarrasa
🇪🇸Terrassa, Barcelona, Spain
Hospital Severo Ochoa
🇪🇸Leganes, Madrid, Spain
Hospital Ntra Sra del Pino/Sabinal
🇪🇸las Palmas de Gran Canaria, Canarias, Spain
Hospital de la Ribera
🇪🇸Alzira, Spain
Hospital Universitario Salamanca
🇪🇸Salamanca, Spain
Hospital Arnao de Vilanova
🇪🇸Valencia, Spain
Hospital U. La Fe (H. Infantil)
🇪🇸Valencia, Spain
Hospital de Tarragona "Joan XXIII"
🇪🇸Tarragona, Spain
Hospital Rio Hortega
🇪🇸Valladolid, Spain
Hospital C. de Valladolid
🇪🇸Valladolid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital U. La Fe
🇪🇸Valencia, Spain
Hospital C. de Barcelona
🇪🇸Barcelona, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Clínica Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Reina Sofia
🇪🇸Murcia, Spain
Complexo H. Xeral-Calde
🇪🇸Lugo, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital General de Murcia
🇪🇸Murcia, Spain
H. Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Carlos Haya
🇪🇸Málaga, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital U. Marques de Valdecilla
🇪🇸Santander, Spain
Hospital U. Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Aránzazu
🇪🇸Santander, Spain
Hospital Clínico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Vírgen del Rocío
🇪🇸Sevilla, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
Hospital General U. de Valencia
🇪🇸Valencia, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital C.U. De Zaragoza
🇪🇸Zaragoza, Spain
Hospital do Meixoeiro
🇪🇸Vigo, Spain
Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Niño Jesus
🇪🇸Sabadell, Barcelona, Spain