Cardiology
Conditions
Interventions
Rituximab plus standard of care
Sponsors
Fondation Coeur et Arteres
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Children aged between >= 5 and < 17 years old; - Diagnosed acute rheumatic fever with at least one progressive rheumatic valvular lesion confirmed through a cardiac echography. - Informed consent, signed and dated
Exclusion criteria
Exclusion criteria: - Simultaneous active infection, such as HIV, hepatitis B, C, tuberculosis, Epstein-Barr virus (EBV), or history of frequent, unusual or serious infections ; - Pathologies likely to affect immunity (cancer, multiple sclerosis, diabetes, other auto-immune diseases) - Recent history of drug administration that may affect the immune system, for the past 4 weeks (immunosuppressive drugs, corticosteroids, anticancer drugs); - Hypersensitivity reaction to rituximab or one of its components. Hypersensitivity to penicillin - History of monoclonal antibodies administration - Recent vaccination (less than a month) or planned within the 12 months after randomization; - History of heart failure - Renal failure with a creatinine clearance 2,5 the normal superior limit) - Any acute or chronic infection clinically significant which would limitate the patient's capacity to follow up the study protocol, which remains under appreciation of the investigator. - Any participation in another clinical trial in the 6 months before the pre-randomization visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rheumatic valvular lesions rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of rheumatic valvular lesions;Serious adverse events rates | — |
Countries
Senegal
Contacts
Public ContactXavier Jouven
Professor
Outcome results
None listed