Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki D… (NCT01917721) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease
United States26 participantsStarted 2013-10
Plain-language 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 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.
Who can participate
Age range
1 Month – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
.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
. Patients with clinically incomplete KD.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing doxycycline specifically to prevent coronary artery dilation getting worse in kids with Kawasaki disease — how does my child's current coronary artery Z-score compare to what this trial is studying, and does that make this worth discussing as an option?
2Since this is a Phase 2 trial, what does that mean for how much is already known about whether doxycycline is safe and effective for children with Kawasaki disease compared to standard treatment?
3The trial is no longer actively enrolling new patients — does that mean there are other ways my child could potentially access doxycycline as part of their care, or should we wait to see results from this study before considering it?
4Kawasaki disease treatment already involves IVIG and aspirin — how would adding doxycycline fit alongside those standard treatments, and are there any known interactions or risks I should understand before asking about this?
5Are there other ongoing or completed studies looking at preventing coronary aneurysm progression in children with Kawasaki disease that my doctor thinks might be more relevant to my child's specific situation right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coronary Artery Diameter Z-score Change
Timeframe: From the acute phase of the disease to the convalescent phase of the disease (average 4 weeks, range 3-8 weeks)