Etiology Study of Kawasaki Disease
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|ClinicalTrials.gov Identifier: NCT00154596|
Recruitment Status : Unknown
Verified March 2015 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 12, 2005
Last Update Posted : March 17, 2015
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:
- fever for over 5 days
- neck lymphadenopathy
- lip fissure and/or strawberry tongue
- skin rash
- nonpurulent bulbar conjunctivitis
- palm/sole erythema and induration followed by desquamation, or coronary artery aneurysm with less than 5 of the above manifestations (atypical Kawasaki disease)
The KD cases will receive virological (virus isolation from the blood, throat swabs and rectal swabs or stool, gene chip for possible viruses from stored RNA and DNA), bacterial (blood, throat swabs and stool: bacterial culture and stored strain for further toxin or superantigen detection), and serological (Mycoplasma pneumoniae, Chlamydiae pneumoniae, ASLO, HHV6, EV71, peptide library approach for auto-antibody or pathogen-related antibody, stored serum for further workup) workup. Stored DNA from the blood will also be performed.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Etiology Study of Kawasaki Disease--A Prospective Household and Case Control Study|
|Study Start Date :||February 2004|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Viral infections associated with Kawasaki disease [ Time Frame: 2014/3 ]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).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154596
|Contact: Luan-Yin Chang, MD, PhD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Luan-Yin Chang, MD, PhD 886-2-23123456 ext 3245 email@example.com|
|Principal Investigator: Luan-Yin Chang, MD, PhD|
|Principal Investigator:||Luan-Yin Chang, MD, PhD||National Taiwan University Hospital|