Patients Who Underwent AllograftADENOCLEARNCT03481244
Treatment of Adenovirus Disseminated Infections in Hematopoietic Stem Cell Transplant Patients With Adenovirus Digestive Replication
An observational study of Patients Who Underwent Allograft, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 20 years
- Conditions the study is for
- Patients Who Underwent Allograft
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 20 years
- All sexes
- Child, Adult
Study population: any patient age above 2 month- and under 20 year- old receiving an allogeneic hematopoietic stem cell transplant
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Treatment of Adenovirus Disseminated Infections in Hematopoietic Stem Cell Transplant Patients With Adenovirus Digestive Replication- A Pharmaco-epidemiological Prospective Study
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.
- Conditions
- Patients Who Underwent Allograft
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 100 days
Secondary outcomes (10)
Adv DNA levels > 5 log10 copies/ml in stool
measured at the end of treatment
Measured: 100 days
Time required achieving 50% decrease of Adv load and undetectable Adv DNA.
Measured: 100 days
Time required achieving 90% decrease of Adv load and undetectable Adv DNA.
Measured: 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.
Measured: 100 days
Incidence of diarrhea
Measured: 100 days
Incidence of acute digestive graft versus host disease (aGvHD)
Measured: 100 days
Overall survival.
Measured: 100 days
Incidence of Adv probable or proven disease
Measured: 100 days
Genotypic analysis of the Adv DNA polymerase
Measured: 100 days
Detection and quantification of herpesviruses in blood
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startApr 2020 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Who Underwent AllograftStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481244
- Sponsor's protocol ID
- K140902J
- Acronym
- ADENOCLEAR
- Status last verified
- Feb 2020
- First submitted
- 22 Mar 2018
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adenovirus Disseminated Infections in Hematopoietic Stem Cell Transplant Patients With Adenovirus Digestive Replication- A Pharmaco-epidemiological Prospective Study
- ClinicalTrials.gov ID
- NCT03481244
- Acronym / sponsor ID
- ADENOCLEAR / K140902J
- Conditions
- Patients Who Underwent Allograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- any patient age above 2 month- and under 20 year- old receiving an allogeneic hematopoietic stem cell transplant
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
10 secondary outcomes
Adv DNA levels > 5 log10 copies/ml in stool
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Who Underwent Allograft, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Le GOFF, MDPhD (33+1 42499493, jerome.le-goff@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of Adv blood infection according to levels of Adv DNA in stool samples. (time frame: 100 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.