An observational study in Patients Who Underwent Allograft, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown. Open to participants aged 2 Months to 20 Years. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Disseminated Adv infections are associated with high morbidity and mortality in HSCT pediatric patients. The most common source of Adv infection after pediatric HSCT is the host digestive tract where latent Adv are reactivated after engraftment. We have shown in a monocentric study that Adv viral load in stools is a predictive factor of blood infection in children with digestive Adv infections. We assume that an early treatment, with antiviral drugs, such as cidofovir and brincidofovir, may avoid severe Adv infections and diseases and thus that molecular surveillance in stool is a critical factor for the control of Adv reactivations.
The study has two main objectives: (i) confirming the impact of Adv viral load in stools on the occurrence of blood infection based on a multicentric prospective cohort study design; and (ii) determining the prognostic and predictive factors for efficacy and toxicity of antiviral drugs, such as brincidofovir and cidofovir.
any patient age above 2 month- and under 20 year- old receiving an allogeneic hematopoietic stem cell transplant
Exclusion Criteria:
rate of Adv blood infection according to levels of Adv DNA in stool samples.
Adv blood infection is defined as plasma Adv DNA level greater than 200 copies per milliliter
Time frame: 100 days
rate of response to antiviral drugs
Success will be defined as undetectable level of DNA of Adv in blood after a maximum of 4 weeks of treatment. After 4 weeks of treatment any detectable level of Adv DNA will be considered as a failure.
Time frame: 100 days
Adv DNA levels > 5 log10 copies/ml in stool
measured at the end of treatment
Time frame: 100 days
Time required achieving 50% decrease of Adv load and undetectable Adv DNA.
Time frame: 100 days
Time required achieving 90% decrease of Adv load and undetectable Adv DNA.
Time frame: 100 days
Incidence of Adv probable or proven disease
We will use the definitions recommended by ECIL (detailed in Appendix 1). * Digestive infection: positive Adv PCR in stool * Local infection: positive Adv PCR in biopsy material or body fluids other than peripheral blood. * Systemic infection/viremia: positive Adv PCR in peripheral blood. * Probable disease: Adv infection plus corresponding symptoms and signs without histological confirmation. * Proven disease: Adv infection plus corresponding symptoms related to the infection and histological confirmation of Adv in the appropriate location.
Time frame: 100 days
Incidence of diarrhea
Time frame: 100 days
Incidence of acute digestive graft versus host disease (aGvHD)
Time frame: 100 days
Overall survival.
Time frame: 100 days
Incidence of Adv probable or proven disease
Time frame: 100 days
Genotypic analysis of the Adv DNA polymerase
Time frame: 100 days
Detection and quantification of herpesviruses in blood
Time frame: 100 days
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Assistance Publique - Hôpitaux de Paris