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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015437
Receipt No. R000017900
Scientific Title A multicenter, randomized control study to assess the safety and efficacy of IVIG plus clarithromycin, a biofilm modulator for Kawasaki disease.
Date of disclosure of the study information 2014/10/15
Last modified on 2016/04/11

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Basic information
Public title A multicenter, randomized control study to assess the safety and efficacy of IVIG plus clarithromycin, a biofilm modulator for Kawasaki disease.
Acronym A multicenter, randomized control study to assess the safety and efficacy of IVIG plus clarithromycin, a biofilm modulator for Kawasaki disease (KPISG-KYUKID)
Scientific Title A multicenter, randomized control study to assess the safety and efficacy of IVIG plus clarithromycin, a biofilm modulator for Kawasaki disease.
Scientific Title:Acronym 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.

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

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
1st name
Middle name
Last name Hisanori Nishio
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Pediatrics
Zip code
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
1st name
Middle name
Last name Etsuro Nanishi
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Pediatrics
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 15 Day
Date of IRB
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

Other
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-open-bin/ctr_e/ctr_view.cgi?recptno=R000017900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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