Cytomegalovirus Infection
Conditions
Keywords
Cytomegalovirus infection
Brief summary
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
Detailed description
Clinical trial with a drug in new conditions of use
Interventions
DRUGValganciclovir
900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks
Sponsors
PETHEMA Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years old * Any patients with allogenic TPH * Following in post-TPH with antigenemia or PCR-CMV * CMV in blood test detected by antigenemia or PCR before the day 180 post-TPH * The beginning of treatment must be Duch early as possible. Maximum in the 72 hours from the antigenemia or PCR-CMV detection * Be the first or second time of a CMV infection * Sign the informed consent * Pregnancy negative test in fertile age patients
Exclusion criteria
* Patients received auto or syngenic TPH * Patients \<50 kg weight * Known allergy or hypersensibility patients to valganciclovir, ganciclovir or aciclovir * Digestive intolerant: nauseous, vomit and or diarrhea that could difficult oral administration of valganciclovir * Patients that presents CMV infection or that is being evaluated for suspected CMV * Patients that have presented \>2 CMV infection episode, before the current one * Severe liver disease defined by bilirubin ≥ 10mg/dL * Treated with: foscarnet, ganciclovir, cidofovir or another antiviral drug active to CMV, in the previous 30 days at the current episode * Neutrophils \< 500 /µL at the beginning of valganciclovir treatment. Patients with \>500 PMN/µL and \< 1000/µL must start a G-CSF treatment to get neutrophils value \> 1000/µL * Platelets \< 25/mm3 even receiving transfusion * Clearance Creatinine \< 10mL/min or dialysed patients * Pregnancy or lactant women * Other contraindication detailed in the filling card * Previous inclusión in this study at the treated group. Is allowed that a patient participate as a control case and after that receive valganciclovir treatment in after CMV episode
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment. | 1 year |
Countries
Spain
Outcome results
None listed