Trial Outcomes & Findings for Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease (NCT NCT01917721)
NCT ID: NCT01917721
Last Updated: 2026-06-03
Results Overview
We will assess the Z-score change (decrease of the Z-scores expressed as a positive number) of the coronary artery diameter measurements from the acute phase to the convalescent phase of the disease (average 4 weeks, range 3-8 weeks). Z-scores of the coronary arteries correspond to coronary artery diameter values measured in mm. A Z-score of 0 corresponds to the mean of the population. A Z-score higher than 0 corresponds to a coronary artery diameter larger than that of the mean. A Z-score exceeding 2 identifies coronary arteries that are considered dilated/abnormal. A Z-score exceeding 2.5 identifies coronary artery aneurysms. A Z-score change of 1 corresponds to a decrease of the Z-score of coronary arteries by 1 standard deviation.
ACTIVE_NOT_RECRUITING
PHASE2
26 participants
From the acute phase of the disease to the convalescent phase of the disease (average 4 weeks, range 3-8 weeks)
2026-06-03
Participant Flow
Participant milestones
| Measure |
Doxycycline
These patients will receive doxycycline at the acute phase of their disease
Doxycycline: The interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 21 days besides receiveing standard care: IVIG and/or Remicade.
|
Placebo
The comparative arm of the study will receive standard care and placebo for Kawasaki disease, but not doxycycline
Placebo: Standard medical care and placebo will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease
Baseline characteristics by cohort
| Measure |
Doxycycline
n=15 Participants
These patients will receive doxycycline at the acute phase of their disease
Doxycycline: The interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 21 days besides receiveing standard care: IVIG and/or Remicade.
|
Placebo
n=11 Participants
The comparative arm of the study will receive standard care and placebo for Kawasaki disease, but not doxycycline
Placebo: Standard medical care and placebo will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.22 years
n=20 Participants
|
2.09 years
n=20 Participants
|
2.21 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=20 Participants
|
11 participants
n=20 Participants
|
26 participants
n=40 Participants
|
|
Coronary Artery Dilation
RCA (right coronary artery)
|
2.51 Z-score
n=20 Participants
|
2.42 Z-score
n=20 Participants
|
2.47 Z-score
n=40 Participants
|
|
Coronary Artery Dilation
LAD (left anterior descending coronary artery)
|
3.36 Z-score
n=20 Participants
|
2.76 Z-score
n=20 Participants
|
3.3 Z-score
n=40 Participants
|
PRIMARY outcome
Timeframe: From the acute phase of the disease to the convalescent phase of the disease (average 4 weeks, range 3-8 weeks)Population: 1 patient was missing follow up data and 1 patient who was an extreme outlier was removed from analysis.
We will assess the Z-score change (decrease of the Z-scores expressed as a positive number) of the coronary artery diameter measurements from the acute phase to the convalescent phase of the disease (average 4 weeks, range 3-8 weeks). Z-scores of the coronary arteries correspond to coronary artery diameter values measured in mm. A Z-score of 0 corresponds to the mean of the population. A Z-score higher than 0 corresponds to a coronary artery diameter larger than that of the mean. A Z-score exceeding 2 identifies coronary arteries that are considered dilated/abnormal. A Z-score exceeding 2.5 identifies coronary artery aneurysms. A Z-score change of 1 corresponds to a decrease of the Z-score of coronary arteries by 1 standard deviation.
Outcome measures
| Measure |
Doxycycline
n=13 Participants
These patients will receive doxycycline at the acute phase of their disease
Doxycycline: The interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 21 days besides receiveing standard care: IVIG and/or Remicade.
|
Placebo
n=11 Participants
The comparative arm of the study will receive standard care and placebo for Kawasaki disease, but not doxycycline
Placebo: Standard medical care and placebo will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.
|
|---|---|---|
|
Coronary Artery Diameter Z-score Change
RCA (right coronary artery)
|
1.56 Z-score
Interval 0.1 to 2.25
|
1.25 Z-score
Interval 0.71 to 1.99
|
|
Coronary Artery Diameter Z-score Change
LAD (left anterior descending coronary artery)
|
1.45 Z-score
Interval 1.22 to 2.49
|
1.98 Z-score
Interval 0.81 to 3.84
|
SECONDARY outcome
Timeframe: 3 weeksWe will draw blood samples before, during and after the administration of doxycyline to assess the effect on MMP-9 (matrix metalloproteinase 9).
Outcome measures
| Measure |
Doxycycline
n=13 Participants
These patients will receive doxycycline at the acute phase of their disease
Doxycycline: The interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 21 days besides receiveing standard care: IVIG and/or Remicade.
|
Placebo
n=11 Participants
The comparative arm of the study will receive standard care and placebo for Kawasaki disease, but not doxycycline
Placebo: Standard medical care and placebo will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.
|
|---|---|---|
|
Assess the Change in MMP-9 Level
|
90 microgram / mililiter
Interval 50.0 to 120.0
|
80 microgram / mililiter
Interval 50.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 weeksWe 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).
Outcome measures
| Measure |
Doxycycline
n=13 Participants
These patients will receive doxycycline at the acute phase of their disease
Doxycycline: The interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 21 days besides receiveing standard care: IVIG and/or Remicade.
|
Placebo
n=11 Participants
The comparative arm of the study will receive standard care and placebo for Kawasaki disease, but not doxycycline
Placebo: Standard medical care and placebo will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.
|
|---|---|---|
|
Assess a Change in TIMP Level
|
105 microgram / mililiter
Interval 90.0 to 115.0
|
115 microgram / mililiter
Interval 95.0 to 120.0
|
Adverse Events
Doxycycline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doxycycline
n=15 participants at risk
These patients will receive doxycycline at the acute phase of their disease
Doxycycline: The interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 21 days besides receiveing standard care: IVIG and/or Remicade.
|
Placebo
n=11 participants at risk
The comparative arm of the study will receive standard care and placebo for Kawasaki disease, but not doxycycline
Placebo: Standard medical care and placebo will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
3/15 • Number of events 3 • 24 months
|
18.2%
2/11 • Number of events 3 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
26.7%
4/15 • Number of events 4 • 24 months
|
27.3%
3/11 • Number of events 3 • 24 months
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 3 • 24 months
|
18.2%
2/11 • Number of events 2 • 24 months
|
|
Skin and subcutaneous tissue disorders
Sun sensitivity
|
6.7%
1/15 • Number of events 2 • 24 months
|
0.00%
0/11 • 24 months
|
|
Cardiac disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • 24 months
|
0.00%
0/11 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place