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Kawasaki Disease | Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease

Kawasaki Disease research study

What is the primary objective of this study?

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 25 children with KD and enlarged coronary arteries for two 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.

Who is eligible to participate?

Inclusion Criteria: Treatment arm: Patients aged 1 month to 18 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 +3 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 +3 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Kawasaki Disease

Coronary Aneurysm

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DoxycyclineThe interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 14 days besides receiveing standard care: IVIG and/or Remicade.

Drug:Standard careStandard medical care will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DoxycyclineThese patients will receive doxycycline at the acute phase of their disease

Standard careThe comparative arm of the study will receive standard care for Kawasaki disease, but not doxycycline

Study Status

Recruiting

Start Date: October 2013

Completed Date: December 2018

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Coronary artery diameter change

Secondary Outcome: Assess the change in MMP-9 level

Study sponsors, principal investigator, and references

Principal Investigator: Andras Bratincsak, MD PhD

Lead Sponsor: Hawaii Pacific Health

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01917721

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