ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Bicêtre Hospital - APHP, Pediatric intensive care unit | Le Kremlin-Bicêtre | France |
More Assistance Publique - Hôpitaux de Paris trials in France
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