eligibility_summary
Eligible: children 5–<17 with acute rheumatic fever and ≥1 progressive valvular lesion on echo, parental consent. Exclude: active HIV/HBV/HCV/TB/EBV or clinically significant/recurrent infections, immune disorders, immunosuppressants/chemo/steroids in past 4 wks, allergy to rituximab or penicillin, prior mAbs, recent (<1 mo) or planned vaccination (12 mo), heart failure, CrCl<45, pregnancy, Guillain-Barré, Hb<8.5, Plt<100, ANC<1.5, WBC<3, AST/ALT>2.5×ULN, other trial <6 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 2, open-label RCT in children with acute rheumatic fever (carditis), testing rituximab + standard of care (SOC) vs SOC alone. Interventions and mechanisms: - Rituximab: chimeric anti-CD20 monoclonal antibody (immunotherapy) given IV (375 mg/m² ×2, 14 days apart). Mechanism: depletes CD20+ B lymphocytes via complement-dependent cytotoxicity/ADCC/apoptosis, aiming to reduce autoantibody production and immune-complex–mediated inflammation in rheumatic carditis. - SOC: penicillin-based antibiotics (beta-lactam) eradicating group A Streptococcus by inhibiting bacterial cell-wall synthesis, anti-inflammatory agents/steroids may be used to suppress COX/proinflammatory cytokine signaling. Cells/pathways targeted: B cells (CD20), humoral autoimmunity, immune-complex/cytokine pathways, bacterial pathogen control (Streptococcus pyogenes).