A multicenter, randomized control study to assess the safety and efficacy of IVIG plus clarithromycin, a biofilm modulator for Kawasaki disease.
- Conditions
- Kawasaki disease
- Registration Number
- JPRN-UMIN000015437
- Lead Sponsor
- Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method