ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07371689EU 2025-521478-32-00
- Record updated
- 28 January 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Administration of a live vaccine in the 4 weeks prior to inclusion; Patients with overt concomitant bacterial infection; Patients previously treated with another biotherapy; 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 any type of immunodeficiency or cancer; 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; 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); Children weighing less than 5 Kgs; Known anterior cardiomyopathy or operated cardiopathy; Anti TNF-α within the past 14 days; 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).