Kawasaki Disease Clinical Trial
Official title:
Phase 2 Study to Assess the Efficacy and Safety of Doxycycline in Preventing Coronary Artery Aneurysm Formation and Progression
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 one third of children develop enlargement of the coronary arteries that can
lead to serious complications such as coronary artery stenosis, heart attack and even death.
Kawasaki disease is the most common heart disease in children in the USA and it is especially
common among the children of Hawaii. Every year, 50-90 children are diagnosed with KD in
Hawaii and unfortunately there is no medication available to successfully prevent coronary
artery damage in a subset of cases.
During the first few weeks of the illness, cells of the immune system attack the coronary
arteries and release a special substance (MMP) that is responsible for the coronary artery
enlargement. There is a common antibiotic, doxycycline that can specifically block the action
of this special substance (MMP). Research done on animals with KD showed that doxycycline was
able to block this special substance and prevent enlargement of coronary arteries. Research
in adults with enlargement of the main artery in their abdomen also showed that doxycycline
may improve the outcome. Based on these studies doxycycline may be a promising therapy for
children with KD, who develop enlargement of the coronary arteries.
The investigators' proposed research study will assess the usefulness of doxycycline in
preventing the progressive enlargement of coronary arteries in children with KD. The
investigators plan to perform a small (pilot) study to evaluate how good is doxycycline in
preventing coronary artery enlargement. The investigators will treat 50 children with KD and
enlarged coronary arteries for three weeks with doxycycline and assess the change in coronary
arteries as well as the blood levels of the special substance (MMP). If doxycycline proves to
be beneficial in this small study, the investigators are going to design a large research
study involving multiple institutions on Hawaii and the mainland and will recruit more
children to be certain about the value of the proposed treatment. The investigators' proposal
may change the treatment protocol of KD and could present a possible treatment for children
with enlarged coronary arteries preventing potentially devastating consequences.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 21 Years |
Eligibility |
Inclusion Criteria: Treatment arm: Patients aged 1 month to 21 years with confirmed KD will be included in the study if they meet the following criteria: 1. 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. 2. Patients with aneurysms of the right or left main coronary arteries during the acute febrile phase of KD. 3. 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. 1.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 Criteria: The following patients will be excluded from this study: 1. Patients with clinically incomplete KD. 2. Patients whose parents refuse to administer doxycycline. 3. Patients with acute renal failure. 4. Patients with chronic liver and kidney disease. |
Country | Name | City | State |
---|---|---|---|
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Hawaii Pacific Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Coronary artery diameter change | We will assess the change (+ or -) of coronary artery diameter from the beginning of doxycycline administration to the end of doxycycline administration and for an additional 2 months beyond that. | 24 months | |
Secondary | Assess the change in MMP-9 level | We will draw blood samples before, during and after the administration of doxycyline to assess the effect on MMP-9 (matrix metalloproteinase 9). | 24 months | |
Secondary | Assess a change in TIMP level | We will draw blood samples before, during and after the administration of doxycyline to assess the effect on MMP-9 (matrix metalloproteinase 9) and TIMP (tissue inhibitor of matrix metalloproteinase). | 24 months |
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