Status:
UNKNOWN
Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease
Lead Sponsor:
Hawaii Pacific Health
Conditions:
Kawasaki Disease
Coronary Aneurysm
Eligibility:
All Genders
1-21 years
Phase:
PHASE2
Brief Summary
Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and blood vessels including the coronary arteries of the heart. Despite the currently available therapy, about...
Detailed Description
This research study attempts to reveal whether coronary artery dilation in patients with Kawasaki disease refractory to standard therapy could be prevented using a matrix metalloproteinase inhibitor: ...
Eligibility Criteria
Inclusion
- Treatment arm: Patients aged 1 month to 21 years with confirmed KD will be included in the study if they meet the following criteria:
- Patients with dilation of the right or left anterior descending coronary artery beyond a z-score of +2.5 during the acute febrile phase of KD.
- Patients with aneurysms of the right or left main coronary arteries during the acute febrile phase of KD.
- Patients with refractory KD after initial treatment with IVIG and dilated coronary arteries on an echocardiogram during the first month of KD.
- Comparison arm: Patients aged 1 month to 18 years with confirmed KD, who do not meet inclusion criteria to be included in the treatment group.
- Patients with right or left anterior descending coronary artery measurements below a z-score of +2.5 during the acute febrile phase of KD.
Exclusion
- The following patients will be excluded from this study:
- Patients with clinically incomplete KD.
- Patients whose parents refuse to administer doxycycline.
- Patients with acute renal failure.
- Patients with chronic liver and kidney disease.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01917721
Start Date
October 1 2013
End Date
November 1 2022
Last Update
August 28 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826