Clinical Trial: Etiology Study of Kawasaki Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Etiology Study of Kawasaki Disease--A Prospective Household and Case Control Study
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:
- 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.
Detailed Summary:
Patient Selection and Family Surveillance: At National Taiwan University Hospital in Taiwan, we will study patients who fulfill the criteria of Kawasaki disease or atypical Kawasaki disease and their household family members from 2004 to Dec 2005. Institutional Review Board approval will be obtained for this study and informed consents will be obtained from all subjects or their parents. If patients at the emergent service, outpatient clinic or inpatient ward had clinical syndromes suggestive of EV71 infection, they and their household family members were asked to participate in the study. Throat and rectal swabs for virus isolation, and the first blood sample. Clinical manifestations, courses and outcomes were recorded. If at any point the patients suspected of infection displayed clinical symptoms, the other family members in the same household were asked to undergo screening by virus isolation of throat swabs, and received the first blood sample. Questionnaire-based interviews were used to collect information including demographic data, the number of bedrooms in the household, contact time, pattern and presence of current/recent signs and symptoms (cough, rhinorrhea, sore throat, rash, fever, abdominal pain and diarrhea) and preceding contact history with extra-household people who had clinical illness. Follow-up telephone interviews repeated questions about signs and symptoms at 2, 4 and 8-week intervals. If any household family member reported experiencing signs or symptoms suggestive of Kawasaki disease during the follow-up period, the household member will receive further clinical assessment and repeated laboratory investigation for Kawasaki disease. A second blood sample was obtained from the KD cases and all their household family members 4 weeks after the first blood sample was obtained. Control case selection: An age- and sex-matched control will be randomly selected. The control will be the admitted patients
Sponsor: National Taiwan University Hospital
Current Primary Outcome: Viral infections associated with Kawasaki disease [ Time Frame: 2014/3 ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Taiwan University Hospital
Dates:
Date Received: September 9, 2005
Date Started: February 2004
Date Completion: December 2018
Last Updated: March 15, 2015
Last Verified: March 2015
