ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS

Starting soon · Phase 3 · Has a placebo group

Conditions studied: PEDIATRIC ACUTE MYOCARDITIS

In brief

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.

Key facts

Study ID

NCT07371689

Run by

Assistance Publique - Hôpitaux de Paris

People needed

110

Starts

2026-02-01

Expected to finish

2029-12-01

Last updated by the study team

2026-01-28

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Bicêtre Hospital - APHP, Pediatric intensive care unit — Le Kremlin-Bicêtre, France, France

Full record on ClinicalTrials.gov

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