Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.

Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study. - Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024311

Enrollment

250

Registered

2016-10-06

Start date

2016-12-09

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Kawasaki disease

Interventions

Experimental: Clarithromycin plus intravenous immunoglobulin (IVIG) Drug: Clarithromycin 10 mg/kg/day, po (at least 14 days), IVIG 2 g/kg/day, iv, aspirin 30mg/kg/day (3-5 mg/kg/day after defervesc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed Kawasaki disease patients between 4 months and 5 years old. 2.Febrile patient at enrollment. 3.Patients whose written informed consent has been obtained (from them or from their parents).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Relapse rate of Kawasaki disease (at 4 weeks after treatment)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactKenji Furuno

Fukuoka Children's Hospital General pediatrics

furuno.k@kd-research.com092-682-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026