Trial Outcomes & Findings for KIDCARE (Kawasaki Disease Comparative Effectiveness Trial) (NCT NCT03065244)
NCT ID: NCT03065244
Last Updated: 2021-12-03
Results Overview
A fever will be considered ≥38°C rectally or orally and ≥ 37.5°C axillary. Cessation of fever within 24h of initiation of study treatment with no fever recurrence within next 7 days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
105 participants
Primary outcome timeframe
7 days
Results posted on
2021-12-03
Participant Flow
Participant milestones
| Measure |
IVIG
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
55
|
|
Overall Study
Participants Who Failed 1st Treatment and Crossed Over to Receive Other Treatment
|
22
|
9
|
|
Overall Study
COMPLETED
|
47
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
IVIG
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Diagnosed with a different disease
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
Baseline characteristics by cohort
| Measure |
IVIG
n=49 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=54 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.1 years
n=99 Participants
|
3.6 years
n=107 Participants
|
2.9 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multi-race
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
WBC(white blood cells count)
|
13.6 cells*10^9/L
n=99 Participants
|
12.8 cells*10^9/L
n=107 Participants
|
13.0 cells*10^9/L
n=206 Participants
|
|
Z-Worst
|
1.3 Standard Deviation units
n=99 Participants
|
1.1 Standard Deviation units
n=107 Participants
|
1.3 Standard Deviation units
n=206 Participants
|
|
Illness Day at first IVIG
|
6.0 days
n=99 Participants
|
6.0 days
n=107 Participants
|
6.0 days
n=206 Participants
|
|
Incomplete KD
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
ANC (absolute neutrophil count
|
9384.0 cells
n=99 Participants
|
8449.0 cells
n=107 Participants
|
9062.0 cells
n=206 Participants
|
|
zHgb
|
-2.3 g/dL
n=99 Participants
|
-2.3 g/dL
n=107 Participants
|
-2.3 g/dL
n=206 Participants
|
|
PLT (platelet count)
|
359.5 cells*10^9/L
n=99 Participants
|
342.0 cells*10^9/L
n=107 Participants
|
349.0 cells*10^9/L
n=206 Participants
|
|
ESR (erythrocyte sedimentation rate),
|
68.5 mm/h
n=99 Participants
|
56.5 mm/h
n=107 Participants
|
63.0 mm/h
n=206 Participants
|
|
CRP (C-reactive protein)
|
9.0 mg/dL
n=99 Participants
|
14.1 mg/dL
n=107 Participants
|
12.0 mg/dL
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysA fever will be considered ≥38°C rectally or orally and ≥ 37.5°C axillary. Cessation of fever within 24h of initiation of study treatment with no fever recurrence within next 7 days.
Outcome measures
| Measure |
IVIG
n=49 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=52 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days.
|
25 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 24hChange in white blood cell count (WBC), between baseline and 24 hours and 2 weeks following study treatment.
Outcome measures
| Measure |
IVIG
n=48 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=52 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.
Change WBC (Baseline & 24 hr after study treatment completion)
|
-2.05 cells* 10^9/L
Interval -6.03 to 2.85
|
0.15 cells* 10^9/L
Interval -2.43 to 4.6
|
|
Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.
Change WBC (Baseline & Follow-up Visit )
|
-4.9 cells* 10^9/L
Interval -9.7 to 13.4
|
-3.5 cells* 10^9/L
Interval -7.7 to 1.25
|
SECONDARY outcome
Timeframe: 2 weeksZworst score is defined as the largest internal diameter of either the right coronary or left anterior descending arteries normalized for body surface area and expressed as standard deviation units from the mean. A Z-score \>= 2.5 is considered a aneurysm according to the American Heart Association criteria.
Outcome measures
| Measure |
IVIG
n=45 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=45 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Change in Zworst Score Between Baseline and 2-week (± 4 Days) Echocardiograms
|
-0.31 Standard Deviation units
Interval -0.81 to 0.06
|
-0.01 Standard Deviation units
Interval -0.42 to 0.68
|
SECONDARY outcome
Timeframe: 7 daysDetermine the number of days a participant had a fever once the participant has been enrolled into the study.
Outcome measures
| Measure |
IVIG
n=48 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=52 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Total Number of Fever Days (24 Hour Period With a T≥38.0°C) From Enrollment
|
2 days
Interval 1.0 to 3.3
|
1 days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 2 weeksHow long a participant was hospitalized for.
Outcome measures
| Measure |
IVIG
n=48 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=25 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Duration of Hospitalization
|
4 days
Interval 3.0 to 6.0
|
2.5 days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 7 daysDetermine any complications and/or reactions to each treatment.
Outcome measures
| Measure |
IVIG
n=49 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=54 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Number of Participants With IVIG and Infliximab Infusion Reactions and Complications
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24hChange in absolute neutrophil count (ANC) between baseline and 24 hours and 2 weeks following study treatment.
Outcome measures
| Measure |
IVIG
n=48 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=52 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Change in Absolute Neutrophil Count (ANC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.
Change ANC(Baseline & Follow-up visit)
|
-5853.5 cells
Interval -10669.6 to -3236.6
|
-4661.0 cells
Interval -8799.3 to -2731.0
|
|
Change in Absolute Neutrophil Count (ANC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.
Change ANC (Baseline & 24 hr after study treatment completion
|
-3398.4 cells
Interval -7598.45 to 2320.5
|
-1742 cells
Interval -4406.4 to 507.0
|
SECONDARY outcome
Timeframe: 24hChange in C-reactive protein (CRP, mg/dL) concentration between baseline and 24 hours and 2 weeks following study treatment.
Outcome measures
| Measure |
IVIG
n=48 Participants
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=52 Participants
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Change in C-reactive Protein (CRP, mg/dL) Concentration Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.
Change CRP (Baseline & 24 hr after study treatment completion )
|
-4.6 mg/dL
Interval -11.6 to -1.9
|
-4.7 mg/dL
Interval -11.3 to -2.0
|
|
Change in C-reactive Protein (CRP, mg/dL) Concentration Between Baseline and 24 Hours and 2 Weeks Following Study Treatment.
Change CRP(Baseline & Follow-up visit)
|
-8.6 mg/dL
Interval -15.9 to -4.7
|
-13.4 mg/dL
Interval -19.5 to -5.4
|
Adverse Events
IVIG
Serious events: 27 serious events
Other events: 6 other events
Deaths: 0 deaths
Infliximab
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IVIG
n=49 participants at risk
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=54 participants at risk
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
20.4%
10/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
General disorders
Continued Fever after treatment completion and crossover to other study treatment
|
44.9%
22/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
16.7%
9/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
General disorders
Fever following crossover treatment
|
6.1%
3/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
14.8%
8/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Immune system disorders
Dress Syndrome
|
0.00%
0/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
Other adverse events
| Measure |
IVIG
n=49 participants at risk
Patient will be randomly assigned to receive a second IVIG infusion: 2 g/kg IV over 8-10 hours single infusion
IVIG: Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
|
Infliximab
n=54 participants at risk
Patient will be randomly assigned to receive Infliximab 10 mg/kg IV over 2 hours
Infliximab: Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
|
|---|---|---|
|
Gastrointestinal disorders
GI Symptoms
|
8.2%
4/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
5.6%
3/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
5/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
3.7%
2/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis/pain and swelling in extremities
|
8.2%
4/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
3.7%
2/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Blood and lymphatic system disorders
Epistaxis
|
6.1%
3/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
3.7%
2/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
General disorders
Fever after discharge not attributed to KD
|
6.1%
3/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
14.8%
8/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
General disorders
Headache
|
4.1%
2/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Infections and infestations
URI
|
4.1%
2/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Blood and lymphatic system disorders
Leukemoid Reaction
|
0.00%
0/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
General disorders
Chest Pain
|
0.00%
0/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
General disorders
Hyperhidrosis
|
0.00%
0/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Skin and subcutaneous tissue disorders
Pain (IV Site)
|
0.00%
0/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
|
Eye disorders
Color Blindness
|
0.00%
0/49 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
1.9%
1/54 • Adverse event data were collected during the entirety of the study participation which was 6 weeks from study enrollment.
|
Additional Information
Dr. Jane Burns
Dept. of Pediatrics UCSD School of Medicine
Phone: 858-246-0155
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place