Patients Who Underwent Allograft Clinical Trial
— ADENOCLEAROfficial title:
Treatment of Adenovirus Disseminated Infections in Hematopoietic Stem Cell Transplant Patients With Adenovirus Digestive Replication- A Pharmaco-epidemiological Prospective Study
| NCT number | NCT03481244 |
| Other study ID # | K140902J |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2020 |
| Est. completion date | December 2023 |
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.
| Status | Not yet recruiting |
| Enrollment | 400 |
| Est. completion date | December 2023 |
| Est. primary completion date | March 2023 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 2 Months to 20 Years |
| Eligibility |
Inclusion Criteria: - Allogeneic hematopoietic stem cell transplantation from any donor other than full-matched related donor - Age above 2 months and under 20 years - Provide written informed consent from the parents (if <18) and child - Free, informed and written consent, signed by the patient and investigator before any Study examination. If the patient is a minor by child (if possible) and both parents or child and the legal representative in case only one parent is alive Exclusion Criteria: - Hematopoietic stem cell transplantation from full-matched related donor - Females who are pregnant or currently nursing - Any patient receiving cidofovir, ribavirin or any other anti-viral drug under development given in order to treat or prevent - Current disease attributed to adenovirus infection - Lack of affiliation to a social security scheme (as a beneficiary or assignee).Current disease attributed to adenovirus infection |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Secondary | Adv DNA levels > 5 log10 copies/ml in stool | measured at the end of treatment | 100 days | |
| Secondary | Time required achieving 50% decrease of Adv load and undetectable Adv DNA. | 100 days | ||
| Secondary | Time required achieving 90% decrease of Adv load and undetectable Adv DNA. | 100 days | ||
| Secondary | 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. |
100 days | |
| Secondary | Incidence of diarrhea | 100 days | ||
| Secondary | Incidence of acute digestive graft versus host disease (aGvHD) | 100 days | ||
| Secondary | Overall survival. | 100 days | ||
| Secondary | Incidence of Adv probable or proven disease | 100 days | ||
| Secondary | Genotypic analysis of the Adv DNA polymerase | 100 days | ||
| Secondary | Detection and quantification of herpesviruses in blood | 100 days |