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A multicenter clinical trial of a new individualized treatment opinion for Kawasaki disease

A multicenter clinical trial of a new individualized treatment opinion for Kawasaki disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035163
Enrollment
Unknown
Registered
2020-08-02
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Kawasaki Disease

Interventions

IVIG+ low dose methylprednisolone treatment group:IVIG 2g/kg x1 day + methylprednisolone 2mg/kg Bid x 3 days + standard dose of aspirin.
IVIG+ medium dose methylprednisolone treatment group:IVIG 2g/kg x 1 day + methylprednisolone 5mg/kg/ Bid x 3 days + standard dose of aspirin
IVIG treatment group:IVIG 2g/kg x 1 day + standard dose of aspirin
Infliximab treatment group:Infliximab 5 mg/kg x 1 day
Repeat IVIG treatment group:IVIG 2g/kg x 1 day

Sponsors

The Children's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Children with Kawasaki disease diagnosed according to the AHA 2017 Guidelines for diagnosis and Treatment of Kawasaki disease. The standards are as follows: Classic KD is diagnosed in the presence of fever for at least 5 d (the day of fever onset is taken to be the first day of fever) together with at least 4 of the 5 following principal clinical features: 1. Erythema and cracking of lips, strawberry tongue, and/or erythema of oral and pharyngeal mucosa; 2. Bilateral bulbar conjunctival injection without exudate; 3. Rash: maculopapular, diffuse erythroderma, or erythema multiforme-like; 4. Erythema and edema of the hands and feet in acute phase and/or periungual desquamation in subacute phase; 5. Cervical lymphadenopathy (>=1.5 cm diameter), usually unilateral.

Exclusion criteria

Exclusion criteria: 1. Sepsis: There is focus of infection. Fever can be effectively treated with antibiotics, or there is a positive result from blood culture. 2. Scarlet fever: rare within 3 years of age.Patients generally have diffuse skin congestion, no conjunctiva congestion, systemic skin peeling, antibiotic treatment is effective. 3. Measles: Patients often have obvious symptoms of mucosal hyperemia, accompanied by secretions, and Coriolis spot. The rash appears and subsides from top to bottom. 4. Acute lymphadenitis: Cervical lymph node enlargement with local redness, swelling and tenderness, may be accompanied by suppurative lesions, antibiotic treatment is effective. 5. Infectious mononucleosis: Patients often have fever, accompanied by pharyngitis, lymph node enlargement, hepatosplenomegaly.Peripheral blood routine examination showed abnormal lymphocytes, and EB pathogen test could be positive. 6. Exudative pleomorphic erythema: More than two mucosal lesions accompanied by Pseudomembrane, the skin may have herpes scabs. 7. Juvenile rheumatoid arthritis: Children often have prolonged fever, swollen joints and pain, but without hand-foot swelling, and rheumatoid factor is positive.

Design outcomes

Primary

MeasureTime frame
Blood Routine;Erythrocyte sedimentation rate;Hypersensitive C-reactive protein;Liver function;Blood lipids;Renal function;blood electrolytes;N-terminal B-type natriuretic peptide;Serum ferritin;

Countries

China

Contacts

Public ContactGong Fangqi

The Children's Hospital, Zhejiang University School of Medicine

gongfngqi@zju.edu.cn+86 0571-86670008

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026