PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment. SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment. The security will be valued by the % of patients that: Will have negative CMV Neutropenia \<1000 neutrophils/mm3 or \<500 neutrophils/mm3 in the first 35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up (defined by elevated creatinine \>1mg/dL or twice the basal value) CMV illness during the treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of treatment This dates Hill be compared with a patients control group treated with intravenous valganciclovir
Clinical trial with a drug in new conditions of use
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario "Germans Trias i Pujol"
Barcelona, Barcelona, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal, Madrid
Madrid, Madrid, Spain
Hospital Universitario Morales Meseguer, Murcia
Murcia, Murcia, Spain
Hospital general de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.
Time frame: 1 year
To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
Time frame: 1 year
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