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A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease

Primary Purpose

Kawasaki Disease

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

IVIG only

IVIG and Aspirin

About this trial

This is an interventional treatment trial for Kawasaki Disease focused on measuring coronary artery lesions, intravenous immunoglobulin, Kawasaki disease, randomized clinical trial, aspirin

Eligibility Criteria

undefined - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Male or female, under the age of 7 years old.

2. Fulfilled the AHA criteria for KD as explained below:

Fever (more than 38.0℃ ear temperature) > or = 5 days, as well as 4 of the 5 following symptoms
Diffuse mucosal inflammation (strawberry tongue, dry and cracked lips)
Bilateral non-purulent conjunctivitis
Dysmorphous skin rashes
Indurative edematous change over the hands and feet, or desquamation over the fingertips or toes
Cervical lymphadenopathy (one or more nodule at least 1.5 cm in diameter)

3. An informed consent form (ICF, appendix B) signed by the patient or a legal guardian.

Exclusion Criteria:

Had symptoms that did not completely match the KD criteria.
Had an acute fever for < 5 days and >10 days
IVIG treatment at another hospital before being referred to the study center.
Treatment with corticosteroids, other than the inhaled form, in the two weeks prior to joining the study;
The presence of a disease known to mimic Kawasaki disease (such as adenovirus infection, toxic shock syndrome etc.).
Previous KD diagnosis.
Inability to take aspirin (such as history of hypersensitivity to aspirin, G6PD deficiency, recent herpes zoster infection or vaccination, etc.)
Afebrile prior to enrollment
CAL prior to enrollment
Severe concomitant medical disorders (e.g., immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc.)
Suspected to have an infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza
Judged by the researcher to be unsuitable for this trial.
-

Sites / Locations

Kaohsiung Veterans General HospitalRecruiting
Kaohsiung Chang Gung Memorial HospitalRecruiting
Taichung Veterans General HospitalRecruiting
Tungs' Taichung Metroharbor HospitalRecruiting
Linkou Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVIG only

IVIG and Aspirin

Arm Description

All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.

All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.

Outcomes

Primary Outcome Measures

coronary artery lesions

Secondary Outcome Measures

IVIG resistance

Full Information

NCT ID

NCT02951234

First Posted

October 28, 2016

Last Updated

March 5, 2018

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02951234

Brief Title

A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease

Official Title

Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital, Taiwan

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

August 2019 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks.

Detailed Description

Background: Kawasaki disease (KD) is an acute febrile systemic vasculitis most commonly seen in children under the age of 5 years old. High-dose aspirin is often administered, but the duration of such treatment varies. Many centers reduce the aspirin dose once the patient is afebrile, even before treating said patient with IVIG. However, a randomized controlled trial regarding high-dose aspirin in the acute stage of KD has not previously been carried out. Methods/design: This trial has been designed as a multi-center, prospective, randomized controlled, evaluator-blinded trial with two parallel groups to determine whether IVIG alone as the primary therapy in acute-stage KD is as effective as IVIG combined with high-dose aspirin therapy. The primary endpoint is defined as CAL formation at 6-8 weeks. Patients meeting the eligibility criteria are randomly assigned (1:1) to a test group (that receives only IVIG) or a standard group (that receives IVIG plus high-dose aspirin). This clinical trial is conducted at seven medical centers in Taiwan. Discussion: Since high-dose aspirin has significant anti-inflammatory and anti-platelet functions, it does not appear to lower the frequency of disease outcomes. Furthermore, it can decrease hemoglobin levels. Therefore, the investigators have initiated this randomized controlled trial to determine whether high-dose aspirin is necessary in the acute stage of KD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kawasaki Disease

Keywords

coronary artery lesions, intravenous immunoglobulin, Kawasaki disease, randomized clinical trial, aspirin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IVIG only

Arm Type

Experimental

Arm Description

All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin. After fever subsides, low-dose aspirin (3-5mg/kg/day) will be prescribed until 6-8 weeks.

Arm Title

IVIG and Aspirin

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

IVIG only

Intervention Description

All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin.

Intervention Type

Other

Intervention Name(s)

IVIG and Aspirin

Intervention Description

All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside.

Primary Outcome Measure Information:

Title

coronary artery lesions

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

IVIG resistance

Time Frame

7 days

10. Eligibility

Sex

All

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Male or female, under the age of 7 years old. 2. Fulfilled the AHA criteria for KD as explained below: Fever (more than 38.0℃ ear temperature) > or = 5 days, as well as 4 of the 5 following symptoms Diffuse mucosal inflammation (strawberry tongue, dry and cracked lips) Bilateral non-purulent conjunctivitis Dysmorphous skin rashes Indurative edematous change over the hands and feet, or desquamation over the fingertips or toes Cervical lymphadenopathy (one or more nodule at least 1.5 cm in diameter) 3. An informed consent form (ICF, appendix B) signed by the patient or a legal guardian. - Exclusion Criteria: Had symptoms that did not completely match the KD criteria. Had an acute fever for < 5 days and >10 days IVIG treatment at another hospital before being referred to the study center. Treatment with corticosteroids, other than the inhaled form, in the two weeks prior to joining the study; The presence of a disease known to mimic Kawasaki disease (such as adenovirus infection, toxic shock syndrome etc.). Previous KD diagnosis. Inability to take aspirin (such as history of hypersensitivity to aspirin, G6PD deficiency, recent herpes zoster infection or vaccination, etc.) Afebrile prior to enrollment CAL prior to enrollment Severe concomitant medical disorders (e.g., immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases, etc.) Suspected to have an infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza Judged by the researcher to be unsuitable for this trial. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ho-Chang Kuo, MD, PhD

erickuo48@yahoo.com.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Ying-Hsien Huang, MD, PhD

yhhuang123@yahoo.com.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ho-Chang Kuo, MD, PhD

Organizational Affiliation

Kawasaki Disease Center, Kaohsiung Chang Gung Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

ZIP/Postal Code

81362

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ken-Pen Weng, MD

Phone

+886-975581955

kenpenweng@yahoo.com.tw

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ho-Chang Kuo, MD, PhD

erickuo48@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Ying-Hsien Huang, MD, PhD

yhhuang123@yahoo.com.tw

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming-Chih Lin, MD

Phone

+886-917620556

mingclin@gmail.com

Facility Name

Tungs' Taichung Metroharbor Hospital

City

Taichung

ZIP/Postal Code

433

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chung-Chih Kao, MD

Phone

+886-935279276

cckao2cv@yahoo.com

Facility Name

Linkou Chang Gung Memorial Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chih-Jung Chen, MD

chinjung@adm.cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29933749

Citation

Kuo HC, Guo MM, Lo MH, Hsieh KS, Huang YH. Effectiveness of intravenous immunoglobulin alone and intravenous immunoglobulin combined with high-dose aspirin in the acute stage of Kawasaki disease: study protocol for a randomized controlled trial. BMC Pediatr. 2018 Jun 22;18(1):200. doi: 10.1186/s12887-018-1180-1.

Results Reference

derived

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A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease

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