Doxycycline for Kawasaki Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether doxycycline, a common antibiotic, can prevent coronary artery enlargement in children with Kawasaki disease (KD). KD can inflame and damage the heart's arteries, potentially causing serious issues like heart attacks. Researchers aim to determine if doxycycline can prevent this damage by blocking a specific harmful substance. Children with KD who show signs of artery enlargement during the acute febrile phase may be suitable for this study. The trial compares doxycycline treatment to a placebo to assess its effectiveness. As a Phase 2 trial, it focuses on evaluating how well doxycycline works in an initial, smaller group of children with KD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that doxycycline is likely to be safe for children with Kawasaki disease?
Research has shown that doxycycline, a common antibiotic, might be safe and helpful in certain situations. Animal studies on Kawasaki disease (KD) found that doxycycline could prevent the enlargement of coronary arteries, a major concern in KD. In adults with artery problems, doxycycline showed potential in improving health outcomes, suggesting it might be safe and useful for treating artery issues.
Although limited information exists on doxycycline's safety in children with KD, its use in other conditions suggests it is generally safe for most people. However, individual reactions can differ. Participants should monitor for any side effects and consult healthcare providers about any concerns when considering joining a trial involving doxycycline.12345Why do researchers think this study treatment might be promising for Kawasaki disease?
Researchers are excited about using doxycycline for Kawasaki disease because it offers a novel approach by potentially preventing the dilation of coronary arteries, a serious complication in affected children. Unlike current treatments, which mainly focus on reducing inflammation with aspirin and intravenous immunoglobulin (IVIG), doxycycline works by inhibiting enzymes called matrix metalloproteinases (MMPs) that contribute to artery damage. This mechanism could provide an additional layer of protection, making it a promising candidate to improve long-term heart health in young patients with Kawasaki disease.
What evidence suggests that doxycycline might be an effective treatment for Kawasaki disease?
Research has shown that doxycycline, which participants in this trial may receive, might help protect heart arteries in children with Kawasaki disease. Animal studies found that doxycycline can block a substance called MMP, linked to artery widening. In adults, doxycycline has shown potential in improving artery health. These findings suggest that doxycycline could help prevent or reduce artery widening in children with Kawasaki disease, possibly avoiding serious heart problems. Meanwhile, the placebo arm of this trial will receive standard care and a placebo, but not doxycycline.13467
Who Is on the Research Team?
Andras Bratincsak, MD PhD
Principal Investigator
Hawaii Pacific Health
Are You a Good Fit for This Trial?
This trial is for children with Kawasaki Disease who have coronary artery dilation or aneurysms during the acute phase, even after treatment with IVIG. It's not for those whose coronary arteries are less dilated (below a z-score of +2.5) during this phase.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive doxycycline for three weeks to assess its effect on coronary artery dilation in children with Kawasaki disease
Follow-up
Participants are monitored for changes in coronary artery diameter and MMP-9 levels after treatment
Long-term follow-up
Participants are monitored for long-term changes in coronary artery diameter and MMP-9 levels
What Are the Treatments Tested in This Trial?
Interventions
- Doxycycline
- Placebo
Trial Overview
The study tests if Doxycycline can prevent worsening of coronary artery enlargement in kids with Kawasaki Disease. Half will receive Doxycycline and half a placebo over three weeks to see if it reduces artery size and MMP levels.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
These patients will receive doxycycline at the acute phase of their disease
The comparative arm of the study will receive standard care and placebo for Kawasaki disease, but not doxycycline
Doxycycline is already approved in United States, European Union, Canada, Japan for the following indications:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hawaii Pacific Health
Lead Sponsor
Citations
Study design and rationale to assess Doxycycline Efficacy ...
Study design and rationale to assess Doxycycline Efficacy in preventing coronary Artery Lesions in children with Kawasaki Disease (DEAL trial) – a phase II ...
Doxycycline Treatment to Prevent Progressive Coronary ...
Research done on animals with KD showed that doxycycline was able to block this special substance and prevent enlargement of coronary arteries. Research in ...
Study design and rationale to assess Doxycycline Efficacy ...
The efficacy of a 3-week doxycycline course during the acute phase of KD will be evaluated by measuring the decline in coronary artery z-scores from baseline ...
Inhibition of matrix metalloproteinase-9 activity improves ...
Doxycycline can mitigate TNF-α-induced MMP-9-mediated coronary elastin breakdown and improve coronary outcome.
Kawasaki Disease Clinical Research Trials
Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease ... trials showing beneficial effect of doxycycline ...
Doxycycline Treatment to Prevent Progressive Coronary ...
Research done on animals with KD showed that doxycycline was able to block this special substance and prevent enlargement of coronary arteries. Research in ...
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frontiersin.org
frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2020.00094/fullAntibodies and Immunity During Kawasaki Disease
The limited data on adult follow-up cases of KD implies there is a greater lifetime risk of cardiac issues and early mortality (15–18). Even those who had KD ...
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