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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adv DNA levels > 5 log10 copies/ml in stool | measured at the end of treatment | 100 days |
| Time required achieving 50% decrease of Adv load and undetectable Adv DNA. | 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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any patient age above 2 month- and under 20 year- old receiving an allogeneic hematopoietic stem cell transplant
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérôme Le GOFF, MDPhD | Contact | 33+1 42499493 | jerome.le-goff@aphp.fr |
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stool specimens for ADN of adenovirus
| Time required achieving 90% decrease of Adv load and undetectable Adv DNA. | 100 days |
| Incidence of Adv probable or proven disease | We will use the definitions recommended by ECIL (detailed in Appendix 1).
| 100 days |
| Incidence of diarrhea | 100 days |
| Incidence of acute digestive graft versus host disease (aGvHD) | 100 days |
| Overall survival. | 100 days |
| Incidence of Adv probable or proven disease | 100 days |
| Genotypic analysis of the Adv DNA polymerase | 100 days |
| Detection and quantification of herpesviruses in blood | 100 days |