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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary endpoint(s) modifiedv7 Show 4 more changesShow less
    • Enrollment reduced: 50 → 26 participants
    • Results first posted: Jun 3, 2026
    • Primary completion moved earlier from Aug 2026 to Feb 2026
    • Secondary endpoints revised (2)
  2. Notable Primary and study completion dates: Nov 2022 to Aug 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  3. Minor Interventions: Doxycycline (Drug), Standard care (Drug) to Doxycycline (Drug), Placebo (Drug)
    • Eligibility criteria revised
    v5
  4. Notable Primary completion date: Aug 2016 to Nov 2022
    • Study completion date: Dec 2018 to Nov 2022
    v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 2015 to Aug 2016
    • Site details revised
    v3
  6. Notable Primary completion date: Dec 2014 to Oct 2015
    • Interventions: Doxycycline (Drug), Standard care (Other) to Doxycycline (Drug), Standard care (Drug)
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01917721
Lead Sponsor Hawaii Pacific Health
Conditions
(from sponsor)
Kawasaki Disease, Coronary Aneurysm
Related terms Coronary Aneurysm, Mucocutaneous Lymph Node Syndrome
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov