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Starting soon Phase 3

ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS

NCT07371689 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2026-02
Last updated
2026-01-28

Condition(s) studied

PEDIATRIC ACUTE MYOCARDITIS

Investigational drug(s) / intervention(s)

Anakinra, KINERET®

Anakinra, KINERET®: Patients will be randomized to receive Anakinra 4mg/Kg (maximum 100 mg) subcutaneously once a day for 7 days

Study 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.

Eligibility

Sex
ALL
Min age
3 Months
Max age
18 Years
Healthy volunteers
No
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/inducers of cytochrome P450 * Pregnancy or breastfeeding * No affiliation to the Social Security * Current enrollment in another clinical trial * Inability of the legal representative (and the patient, when applicable) to understand the national language (French)

Primary outcome measure(s)

  • Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 3 days after treatment initiation. — 3 days
    Main objective: 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. Primary endpoint: Proportion of children with recovered left ventricle ejection fraction (LVEF ≥ 50%) measured by echocardiography at 3 days after treatment initiation. Patients who die within the first 3 days after treatment initiation or patients who still require ECMO at 3 days after treatment initiation will be considered as a failure.

Trial sites (1)

FacilityCityRegionStatus
Bicêtre Hospital - APHP, Pediatric intensive care unit Le Kremlin-Bicêtre France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07371689 on ClinicalTrials.gov ↗ ← All trials in France