Kawasaki disease
Conditions
Interventions
Intravenous immunoglobulin (2 g/kg/day) over 12 hours with aspirin (30 mg/kg/day). The dosage of aspirin can be decreased to 5 mg/kg/day after becoming afebrile. Clarithromycin (10 mg/kg/day) will b
Sponsors
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Kawasaki disease patients. 2. Infants and children between 4 months and 5 years old. 3. Patient who remain febrile at enrollment. 4. The following Kawasaki disease mimicking diseases will be clinically ruled out: measles or Stevens-Johnson syndrome. 5. Patients whose written informed consent has been obtained (from them or from their parents).
Exclusion criteria
Exclusion criteria: Patients planning to receive systemic steroid therapy in the initial therapy. 2. Patients with past histories of hypersensitivity reaction against clarithromycin or other macrolide drugs. 3. Patients currently receiving medications that are known to interact with clarithromycin (digoxin, carbamazepine, theophylline, aminophylline, cyclosporine, tacrolimus, benzodiazepine, disopyramide, nifedipine, verapamil, sildenafil citrate, warfarin, rifampin etc.) 4. Patients diagnosed on the ninth day of illness or later (the first illness day is defined as the day when the patient develops a fever). 5. Patients with coronary lesions before starting treatment. 6. Patients with past histories of Kawasaki disease (recurrent cases). 7. Patients with serious active bacterial infection as sepsis. 8. Patients having received IVIG within 90 days. 9. Patients with severe underlying disease (immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, collagen diseases, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of fever after enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Z score from baseline (at enrollment) to week 4. 2. Incidence of relapsing Kawasaki disease during study period. 3. Zmax (largest of the echocardiographic measurements of the internal diameter normalized for body surface area) of the proximal right coronary artery and left anterior descending coronary artery at weeks 4 after treatment. 4. Incidence of coronary artery lesions during study period. 5. Incidence of coronary artery lesions at weeks 4 after treatment. 6. The diameter, its change from baseline (at enrollment), z score of the coronary artery at 1, 2, 4 weeks after enrollment. 7. Laboratory blood test data at 1, 2 and 4 weeks after treatment (WBC, Neut%, Hct, Plt, T.Bil, AST, ALT, LDH, Na, BUN, Cr, TP, Alb, CRP). 8. Incidence of need for additional rescue treatment. 9. Frequency of adverse events. | — |
Countries
Japan
Contacts
Public ContactEtsuro Nanishi
Graduate School of Medical Sciences, Kyushu University Department of Pediatrics
Outcome results
None listed