ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS (NCT07371689) | Clinical Trial Compass
Not Yet RecruitingPhase 3
ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS
France110 participantsStarted 2026-02
Plain-language summary
Double blind RCT aiming to compare the efficacy of Anakinra vs placebo, on top of the standard of care, on restoration of myocardial function at 3 days following treatment initiation, in children admitted for acute myocarditis in intensive care units.
Who can participate
Age range3 Months – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children from ≥ 3 months to \< 18 years of age
* Hospitalized in the Intensive Care Unit (ICU) for acute myocarditis defined as : - a reduced left ventricle ejection fraction below 50% and - troponin T rise (\>1.5x normal range), Signed informed consent by legal representative and patient according to the legislation.
Exclusion Criteria:
* Children weighing less than 5 Kgs
* Known anterior cardiomyopathy or operated cardiopathy
* Neutropenia (\< 1,5 × 10\^9 /L).
* Known hypersensitivity to Anakinra or any of its excipients (citric acid anhydrous, sodium chloride, disodium EDTA dihydrate, polysorbate 80, E. coli derived proteins)
* Administration of a live vaccine in the 4 weeks prior to inclusion
* Hepatitis B infection, defined as positive HBsAg and/or detectable HBV DNA (PCR). Patients with increased risk of Tuberculosis (TB) infection
* Recent tuberculosis infection or with active TB
* Close contact with a patient with TB
* Patients recently arrived less than 3 months from a country with high prevalence of TB
* A chest radiograph suggestive of TB
* Patients with overt concomitant bacterial infection
* Patients previously treated with another biotherapy
* Patients with any type of immunodeficiency or cancer
* Anti TNF-α within the past 14 days
* Malignancy or history of malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study Ongoing or recent use of any other medication Known inhibitors/inducer…
What they're measuring
1
Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 3 days after treatment initiation.