UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, randomized control study to assess the safety and efficacy of IVIG plus clarithromycin, a biofilm modulator for Kawasaki disease.
Title of the study (Brief title)	A multicenter, randomized control study to assess the safety and efficacy of IVIG plus clarithromycin, a biofilm modulator for Kawasaki disease (KPISG-KYUKID)
Region	Japan

Condition
Condition	Kawasaki disease
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Implementing a randomized controlled trial to confirm the safety and efficacy of the intravenous immunoglobulin (IVIG) and clarithromycin combined therapy over the standard IVIG alone therapy in terms of the difference between the groups in duration of fever after enrolment after initiating the treatment among pediatric patients of Kawasaki disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Duration of fever after enrolment
Key secondary outcomes	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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 be given for at least 14 days and quitted not less than 7 days after defervescence.
Interventions/Control_2	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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	4 months-old <=
Age-upper limit	72 months-old >
Gender	Male and Female
Key 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).
Key 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.
Target sample size	90

Research contact person
Name of lead principal investigator	Hisanori Nishio
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Pediatrics
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka-city, 812-8582 Japan
TEL	092-642-5421
Email	hnishio@pediatr.med.kyushu-u.ac.jp

Public contact
Name of contact person	Etsuro Nanishi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Pediatrics
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka-city, 812-8582 Japan
TEL	092-642-5421
Homepage URL
Email	nanishi@pediatr.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	九州大学病院（福岡県）、福岡市立こども病院・感染症センター（福岡県）、福岡赤十字病院（福岡県）、山口赤十字病院（山口県）、JCHO九州病院（福岡県）、大分県立病院（大分県）、小倉医療センター（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 15 Day
Anticipated trial start date	2014 Year 10 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 15 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000017900