BridgeMD
ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS
EU CTIS ID: 2025-521478-32-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 likely can't join if
- Children weighing less than 5 Kgs
- 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
- - Patients with increased risk of Tuberculosis (TB ) infection - Recent tuberculosis infection or with active TB o Close contact with a patient with TB o Patients recently arrived less than 3 months from a country with high prevalence of TB o A chest radiograph suggestive of TB
- - Patients with overt concomitant bacterial infection
See the full eligibility 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.
- Children weighing less than 5 Kgs
- 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
- - Patients with increased risk of Tuberculosis (TB ) infection - Recent tuberculosis infection or with active TB o Close contact with a patient with TB o Patients recently arrived less than 3 months from a country with high prevalence of TB o A chest radiograph suggestive of TB
- - Patients with overt concomitant bacterial infection
- - Patients with overt concomitant bacterial infection
- - Patients with any type of immunodeficiency or cancer
- - Inability of the legal representative (and the patient, when applicable) to understand the national language (French)
- Pregnancy** or breastfeeding
- No affiliation to the Social Security
- Current enrollment in another clinical trial
- 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). Due to the urgent need to start treatment, inclusion may occur before hepatitis B screening results are available. If hepatitis B infection is subsequently confirmed, the study treatment will be immediately discontinued.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.