UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024311 |
|---|---|
| Receipt number | R000028001 |
| Scientific Title | Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study. |
| Date of disclosure of the study information | 2016/10/06 |
| Last modified on | 2019/04/09 10:15:57 |
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Basic information
Public title
Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Acronym
Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Scientific Title
Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Scientific Title:Acronym
Clarithromycin plus intravenous immunoglobulin therapy for Kawasaki disease, a phase 3, multicenter, randomized, double blind, placebo control study.
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effect of clarithromycin for Kawasaki disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse rate of Kawasaki disease (at 4 weeks after treatment)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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 defervescence)
Interventions/Control_2
Placebo Comparator:
Placebo plus IVIG
Drug:
Placebo PO (at least 14 days, same volume as active drug), IVIG 2 g/kg/day, aspirin 30mg/kg/day (3-5 mg/kg/day after defervescence)
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.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).
Key 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.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Hara |
Organization
Fukuoka Children's Hospital
Division name
President
Zip code
813-0017
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, Japan
TEL
092-682-7000
harat@pediatr.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Furuno |
Organization
Fukuoka Children's Hospital
Division name
General pediatrics
Zip code
813-0017
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, Japan
TEL
092-682-7000
Homepage URL
furuno.k@kd-research.com
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Children's Hospital
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, Japan
Tel
092-682-7000
furuno.k@kd-research.com
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
福岡市立こども病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
250
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
| 2016 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028001
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