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 range
3 Months – 18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of children with recovered left ventricle ejection fraction ≥ 50% measured by echocardiography at 3 days after treatment initiation.