Etiology Study of Kawasaki Disease

NCT00154596 | Unknown

• 1 other identifier: 930004318
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the infectious etiology of Kawasaki disease (KD); a prospective household and case control study for Kawasaki disease will be done. The investigators will enroll Kawasaki disease cases who have at least five of the following manifestations:

1. 1.fever for over 5 days
2. 2.neck lymphadenopathy
3. 3.lip fissure and/or strawberry tongue
4. 4.skin rash
5. 5.nonpurulent bulbar conjunctivitis
6. 6.palm/sole erythema and induration followed by desquamation, or coronary artery aneurysm with less than 5 of the above manifestations (atypical Kawasaki disease)

Conditions

Kawasaki Disease

Keywords

etiology; transmission; vasculitis; household; etiology of disease

Outcome Measures

Primary Outcomes (1)

• Viral infections associated with Kawasaki disease

  The mean age of the 226 KD cases was 2.07 years, and the male to female ratio was 1.43 (133 boys to 93 girls). Their mean fever duration was 7.5 days with a mean peak temperature of 39.7°C. In addition to the typical symptoms of fever, neck lymphadenopathy, lip fissure and/or strawberry tongue, skin rash, nonpurulent bulbar conjunctivitis, palm/sole erythema, and induration followed by periungual desquamation, these KD cases also exhibited cough (69%), rhinorrhea (58%), and diarrhea (45%). Cases of KD had a significantly higher positive rate of viral isolation in comparison with the control group (7.5% vs. 2.2%, p = 0.02). Compared with the control group, cases of KD were more likely to have overall positive rates of viral PCR (50.4% vs. 16.4%, p \< 0.001) and for various viruses including enterovirus (16.8% vs. 4.4%, p \< 0.001), adenovirus (8.0% vs. 1.8%, p = 0.007), human rhinovirus (26.5% vs. 9.7%, p \< 0.001), and coronavirus (7.1% vs. 0.9%, p = 0.003).

  2014/3

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We will enroll Kawasaki disease cases who have at least five of the following manifestations: 1) fever for over 5 days, 2) neck lymphadenopathy, 3) lip fissure and/or strawberry tongue, 4) skin rah, 5) nonpurulent bulbar conjunctivitis, 6) palm/sole erythema and induration followed by desquamation, or cases with coronary artery aneurysm but less than 5 of the above manifestations (atypical Kawasaki disease).

You may qualify if:

• Patients who fulfill the criteria of Kawasaki disease or atypical Kawasaki disease and their household family members

You may not qualify if:

• Not cases of Kawasaki disease

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

Related Publications (4)

• Chang LY, Chiang BL, Kao CL, Wu MH, Chen PJ, Berkhout B, Yang HC, Huang LM; Kawasaki Disease Research Group. Lack of association between infection with a novel human coronavirus (HCoV), HCoV-NH, and Kawasaki disease in Taiwan. J Infect Dis. 2006 Jan 15;193(2):283-6. doi: 10.1086/498875. Epub 2005 Dec 2.

  PMID: 16362893 RESULT

• Chang LY, Lu CY, Shao PL, Lee PI, Lin MT, Fan TY, Cheng AL, Lee WL, Hu JJ, Yeh SJ, Chang CC, Chiang BL, Wu MH, Huang LM. Viral infections associated with Kawasaki disease. J Formos Med Assoc. 2014 Mar;113(3):148-54. doi: 10.1016/j.jfma.2013.12.008. Epub 2014 Feb 1.

  PMID: 24495555 RESULT

• Tsai HC, Chang LY, Lu CY, Shao PL, Fan TY, Cheng AL, Hu JJ, Yeh SJ, Chang CC, Huang LM. Transmission of acute infectious illness among cases of Kawasaki disease and their household members. J Formos Med Assoc. 2015 Jan;114(1):72-6. doi: 10.1016/j.jfma.2014.07.005. Epub 2014 Sep 6.

  PMID: 25205598 RESULT

• Lee YC, Kuo HC, Chang JS, Chang LY, Huang LM, Chen MR, Liang CD, Chi H, Huang FY, Lee ML, Huang YC, Hwang B, Chiu NC, Hwang KP, Lee PC, Chang LC, Liu YM, Chen YJ, Chen CH; Taiwan Pediatric ID Alliance; Chen YT, Tsai FJ, Wu JY. Two new susceptibility loci for Kawasaki disease identified through genome-wide association analysis. Nat Genet. 2012 Mar 25;44(5):522-5. doi: 10.1038/ng.2227.

  PMID: 22446961 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, throat swab, nasopharyngeal aspiration, and rectal swab will be obtained during acute illness and at convalescence (about 2 weeks after discharge). These specimens will be processed for viral isolation, bacterial culture and toxin detection, PCR, subtractive cloning, VIDISCA, gene chips, peptide library, cytokine/chemokine measurement, antibody detection for specific pathogens, etc. Questionnaire for contact history and clinical symptoms will be performed.

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome; Vasculitis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Luan-Yin Chang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luan-Yin Chang, MD, PhD

CONTACT

886-2-23123456; ly7077@tpts6.seed.net.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2004
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

TW (1)