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Randomized Controlled Trial of Tocilizumab Combined with Anakinra in the Treatment of Pediatric FIRES

Randomized Controlled Trial of Tocilizumab Combined with Anakinra in the Treatment of Pediatric FIRES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126257
Enrollment
Unknown
Registered
2026-06-05
Start date
2026-06-10
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile Infection-Related Epilepsy Syndrome

Interventions

Combined therapy Group:Tocilizumab + Anakinra

Sponsors

Beijing Childrens Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 29 days to 18 years; 2. Meets the diagnostic criteria for FIRES; 3. First onset and can be included in the study during the acute phase of FIRES; 4. The child's guardian fully understands the study content and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to anakinra or tocilizumab injection components; 2. Accompanied by severe heart or kidney failure; 3. FIRES children whose guardians, for various reasons, do not agree to use biological agents or discontinue treatment midway.

Design outcomes

Primary

MeasureTime frame
Glasgow Coma Scale score of children at discharge;

Secondary

MeasureTime frame
Seizure control status;PICU Length of Stay;Duration of mechanical ventilation;Total hospital stay;In-hospital mortality rate;28-day in-hospital mortality;Short-term and long-term (1 month and 6 months after discharge) neurological function (PCPC/POPC);

Countries

China

Contacts

Public ContactQuan Wang

Beijing Childrens Hospital,Capital Medical University

wq_bch@163.com+86 10 59616767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026