UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015437 |
|---|---|
| Receipt number | 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 09:02:00 |
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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
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
nanishi@pediatr.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017900
