Kawasaki disease
Conditions
Brief summary
The main criterion-evaluating efficacy in both groups is: the patient must reach a body (axillary (+0.5°C), tympanic, oral) temperature <38˚C within 2 days after initiation of treatment (considering time of the last escalation dose if any) (i.e. a binary outcome: success/failure).
Detailed description
Temperature <38˚C within 3 days (72h) after initiation of treatment, Decrease of the CRP values from baseline to day 30 (CRP<6 mg/L at day 30), Reduction in physician assessment of disease activity, on a 10 points scale, of at least to 50% between baseline and day 14., Reduction in patient’s parent’s assessment of disease activity, on a 10 points scale, of to at least 50% between baseline and day 14., Resolution of coronary abnormalities; i.e worst Z score <2.5, by echocardiogram if present at day 45., Adverse events: pain/redness at injection site, bacterial infection, hepatitis, macrophage activation syndrome, severe neutropenia,
Interventions
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main criterion-evaluating efficacy in both groups is: the patient must reach a body (axillary (+0.5°C), tympanic, oral) temperature <38˚C within 2 days after initiation of treatment (considering time of the last escalation dose if any) (i.e. a binary outcome: success/failure). | — |
Secondary
| Measure | Time frame |
|---|---|
| Temperature <38˚C within 3 days (72h) after initiation of treatment, Decrease of the CRP values from baseline to day 30 (CRP<6 mg/L at day 30), Reduction in physician assessment of disease activity, on a 10 points scale, of at least to 50% between baseline and day 14., Reduction in patient’s parent’s assessment of disease activity, on a 10 points scale, of to at least 50% between baseline and day 14., Resolution of coronary abnormalities; i.e worst Z score <2.5, by echocardiogram if present at day 45., Adverse events: pain/redness at injection site, bacterial infection, hepatitis, macrophage activation syndrome, severe neutropenia, | — |
Countries
France
Outcome results
None listed