Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
- Conditions
- Kawasaki disease
- Registration Number
- JPRN-UMIN000024311
- Lead Sponsor
- Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 250
Not provided
1.Patients with day 9 of illness or over, when day 1 defined as the first day of fever. 2.Those have received 14/15-membered ring macrolide. 3.Those with coronary artery abnormality at enrollment. 4.Relapse or recurrence of Kawasaki disease. 5.Those with suspicious origin of fever in addition to Kawasaki disease. 6.Those received intravenous immunoglobulin therapy within 90 days before enrollment. 7.Those with severe underlying disease. 8.Those who are receiving systemic immunosuppressant agent such as steroids at the enrollment. 9.Those with prolonged QT interval. 10.Those with a history of hypersensitivity reactions to macrolides. 11.Those who are receiving drugs which interact with clarithromycin 12.Any other patients who are regarded as unsuitable for this study by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse rate of Kawasaki disease (at 4 weeks after treatment)
- Secondary Outcome Measures
Name Time Method 1. Rate of initial treatment failure and recurrence 2. Duration of hospitalization 3. Rate of patient who required additional treatment for Kawasaki disease 4. Period of time between defervescence to relapse 5. Laboratory data (WBC count, %neutrophil, %lymphocyte, %eosinophil, hemoglobin, hematocrit, plt count, TP, Alb, T-Bil, AST, ALT, LDH, Na, BUN, Cr, CRP, sICAM-1, sVCAM-1, IL-6, MIG, TNF-R1, TNF-R2) 6. Maximum coronary z score at week 4, change in z score from baseline to week 4 7. Incidence of coronary artery abnormality 8. Adverse event