Trial · NCT03065244
KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
NCT03065244, Phase 3, Completed, University of California, San Diego; results first posted 2021-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. KIDCARE (Kawasaki Disease Comparative Effectiveness Trial). Trials, record NCT03065244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03065244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)
- NCT number
- NCT03065244
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 105 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Mucocutaneous Lymph Node Syndrome
- Interventions
- IVIG, Infliximab
- First posted
- 2017-02-27
- Last updated
- 2021-12-03
- Results first posted
- 2021-12-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days. | 7 days | 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. |
| Secondary | Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | 24h | Change in white blood cell count (WBC), between baseline and 24 hours and 2 weeks following study treatment. |
| Secondary | Change in Zworst Score Between Baseline and 2-week (± 4 Days) Echocardiograms | 2 weeks | Zworst 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. |
| Secondary | Total Number of Fever Days (24 Hour Period With a T≥38.0°C) From Enrollment | 7 days | Determine the number of days a participant had a fever once the participant has been enrolled into the study. |
| Secondary | Duration of Hospitalization | 2 weeks | How long a participant was hospitalized for. |
| Secondary | Number of Participants With IVIG and Infliximab Infusion Reactions and Complications | 7 days | Determine any complications and/or reactions to each treatment. |
| Secondary | Change in Absolute Neutrophil Count (ANC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | 24h | Change in absolute neutrophil count (ANC) between baseline and 24 hours and 2 weeks following study treatment. |
| Secondary | Change in C-reactive Protein (CRP, mg/dL) Concentration Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | 24h | Change in C-reactive protein (CRP, mg/dL) concentration between baseline and 24 hours and 2 weeks following study treatment. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days. | 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | 24h | cells* 10^9/L | MEDIAN | |
| SECONDARY | Change in Zworst Score Between Baseline and 2-week (± 4 Days) Echocardiograms | 2 weeks | Standard Deviation units | MEDIAN | |
| SECONDARY | Total Number of Fever Days (24 Hour Period With a T≥38.0°C) From Enrollment | 7 days | days | MEDIAN | |
| SECONDARY | Duration of Hospitalization | 2 weeks | days | MEDIAN | |
| SECONDARY | Number of Participants With IVIG and Infliximab Infusion Reactions and Complications | 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Absolute Neutrophil Count (ANC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | 24h | cells | MEDIAN | |
| SECONDARY | Change in C-reactive Protein (CRP, mg/dL) Concentration Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | 24h | mg/dL | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days. | IVIG | 25 | Participants | ||
| Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days. | Infliximab | 40 | Participants | ||
| Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | IVIG | Change WBC (Baseline & 24 hr after study treatment completion) | -2.05 | Inter-Quartile Range -6.03 to 2.85 | cells* 10^9/L |
| Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | Infliximab | Change WBC (Baseline & 24 hr after study treatment completion) | 0.15 | Inter-Quartile Range -2.43 to 4.6 | cells* 10^9/L |
| Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | IVIG | Change WBC (Baseline & Follow-up Visit ) | -4.9 | Inter-Quartile Range -9.7 to 13.4 | cells* 10^9/L |
| Change in White Blood Cell Count (WBC) Between Baseline and 24 Hours and 2 Weeks Following Study Treatment. | Infliximab | Change WBC (Baseline & Follow-up Visit ) | -3.5 | Inter-Quartile Range -7.7 to 1.25 | cells* 10^9/L |
| Change in Zworst Score Between Baseline and 2-week (± 4 Days) Echocardiograms | IVIG | -0.31 | Inter-Quartile Range -0.81 to 0.06 | Standard Deviation units | |
| Change in Zworst Score Between Baseline and 2-week (± 4 Days) Echocardiograms | Infliximab | -0.01 | Inter-Quartile Range -0.42 to 0.68 | Standard Deviation units | |
| Total Number of Fever Days (24 Hour Period With a T≥38.0°C) From Enrollment | IVIG | 2 | Inter-Quartile Range 1 to 3.3 | days | |
| Total Number of Fever Days (24 Hour Period With a T≥38.0°C) From Enrollment | Infliximab | 1 | Inter-Quartile Range 1 to 2 | days |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IVIG | 50 | |
| Overall Study | STARTED | Infliximab | 55 | |
| Overall Study | Participants Who Failed 1st Treatment and Crossed Over to Receive Other Treatment | IVIG | 22 | |
| Overall Study | Participants Who Failed 1st Treatment and Crossed Over to Receive Other Treatment | Infliximab | 9 | |
| Overall Study | COMPLETED | IVIG | 47 | |
| Overall Study | COMPLETED | Infliximab | 51 | |
| Overall Study | NOT COMPLETED | IVIG | 3 | |
| Overall Study | NOT COMPLETED | Infliximab | 4 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | GI Symptoms | Gastrointestinal disorders | IVIG | 4 | 49 | |
| other | GI Symptoms | Gastrointestinal disorders | Infliximab | 3 | 54 | |
| other | Rash | Skin and subcutaneous tissue disorders | IVIG | 5 | 49 | |
| other | Rash | Skin and subcutaneous tissue disorders | Infliximab | 2 | 54 | |
| other | Arthritis/pain and swelling in extremities | Musculoskeletal and connective tissue disorders | IVIG | 4 | 49 | |
| other | Arthritis/pain and swelling in extremities | Musculoskeletal and connective tissue disorders | Infliximab | 2 | 54 | |
| other | Epistaxis | Blood and lymphatic system disorders | IVIG | 3 | 49 | |
| other | Epistaxis | Blood and lymphatic system disorders | Infliximab | 2 | 54 | |
| other | Fever after discharge not attributed to KD | General disorders | IVIG | 3 | 49 | |
| other | Fever after discharge not attributed to KD | General disorders | Infliximab | 8 | 54 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IVIG | 0 | 49 |
| Total, all-cause mortality | Infliximab | 0 | 54 |
| Total, other adverse events | IVIG | 6 | 49 |
| Total, other adverse events | Infliximab | 14 | 54 |
| Total, serious adverse events | IVIG | 27 | 49 |
| Total, serious adverse events | Infliximab | 10 | 54 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34715057 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IVIG vs Infliximab: Number of Participants With Cessation of Fever Within 24h of Initiation of Study Treatment With no Fever Recurrence Within Next 7 Days. | Trial comparisons |
| IVIG vs Infliximab: Number of Participants With IVIG and Infliximab Infusion Reactions and Complications | Trial comparisons |
| IVIG vs Infliximab: deaths from any cause | Trial comparisons |
| IVIG vs Infliximab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03065244
GET https://conductscience.org/api/trials/v1/NCT03065244/results?page=2