Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT04535518
Brief Summary:
This study evaluates the efficacy of the addition of infliximab to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in early regression of coronary artery lesion in patients with Kawasaki disease (KD).
Detailed Description:
This is a multicenter, open-label, blind-end, randomized controlled trial at 5 hospitals in Shanghai, China. The KD children diagnosed within 14 days of onset according to the diagnostic criteria for KD released by American Heart Association (AHA) in 2017 will be considered for participants in the trial. The patients meeting eligibility criteria will be randomly assigned in a 1:1 ratio to the control group (receiving 2 g/kg\*1 IVIG and 30 mg/kg/d aspirin) or intervention group (receiving 2 g/kg\*1 IVIG, 30 mg/kg/d aspirin and additional 5 mg/kg\*1 infliximab) based on the randomly block design (block sizes 4). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, other clinical manifestations, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at least 7 timepoints: at admission, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months after onset of KD to assess the coronary artery lesions.
Study:
NCT04535518
Study Brief:
Protocol Section:
NCT04535518