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Trial record 46 of 6722 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

Treatment of Adenovirus Disseminated Infections in Hematopoietic Stem Cell Transplant Patients With Adenovirus Digestive Replication (ADENOCLEAR)

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ClinicalTrials.gov Identifier: NCT03481244
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease
Patients Who Underwent Allograft

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Adenovirus Disseminated Infections in Hematopoietic Stem Cell Transplant Patients With Adenovirus Digestive Replication- A Pharmaco-epidemiological Prospective Study
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023



Primary Outcome Measures :
  1. rate of Adv blood infection according to levels of Adv DNA in stool samples. [ Time Frame: 100 days ]
    Adv blood infection is defined as plasma Adv DNA level greater than 200 copies per milliliter

  2. rate of response to antiviral drugs [ Time Frame: 100 days ]
    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.


Secondary Outcome Measures :
  1. Adv DNA levels > 5 log10 copies/ml in stool [ Time Frame: 100 days ]
    measured at the end of treatment

  2. Time required achieving 50% decrease of Adv load and undetectable Adv DNA. [ Time Frame: 100 days ]
  3. Time required achieving 90% decrease of Adv load and undetectable Adv DNA. [ Time Frame: 100 days ]
  4. Incidence of Adv probable or proven disease [ Time Frame: 100 days ]

    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.

  5. Incidence of diarrhea [ Time Frame: 100 days ]
  6. Incidence of acute digestive graft versus host disease (aGvHD) [ Time Frame: 100 days ]
  7. Overall survival. [ Time Frame: 100 days ]
  8. Incidence of Adv probable or proven disease [ Time Frame: 100 days ]
  9. Genotypic analysis of the Adv DNA polymerase [ Time Frame: 100 days ]
  10. Detection and quantification of herpesviruses in blood [ Time Frame: 100 days ]

Biospecimen Retention:   Samples Without DNA
stool specimens for ADN of adenovirus


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Ages Eligible for Study:   2 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
any patient age above 2 month- and under 20 year- old receiving an allogeneic hematopoietic stem cell transplant
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481244


Contacts
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Contact: Jérôme Le GOFF, MDPhD 33+1 42499493 jerome.le-goff@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03481244     History of Changes
Other Study ID Numbers: K140902J
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoviridae Infections
DNA Virus Infections
Virus Diseases