Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-01-22
Brief Title:
TREAT-SC Early Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
Sponsor:
Starship Child Health Te Toka Tumai Auckland
Organization:
Starship Child Health Te Toka Tumai Auckland
Study Overview
Official Title:
TREAT-SC A Randomised Double-Blinded Placebo-Controlled Trial of Early Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREAT-SC
Brief Summary:
The purpose of this study is to find out whether an early three-day course of an oral steroid medication dexamethasone can improve the physical and mental recovery and wellbeing for children with Sydenhams chorea
Sydenhams chorea is a condition that impacts approximately 12 of children with acute rheumatic fever It is caused by inflammation in the brain following an abnormal immune response to Group A streptococcus bacterial infection Sydenhams chorea is a movement disorder that causes childrens faces hands and feet to move quickly and uncontrollably and can also affect mood and concentration The physical recovery from Sydenhams chorea can take two to six months but the mental recovery eg mood and concentration can take longer to resolve Sydenhams chorea remains endemic in Māori Pacific Islander Aboriginal and Torres Strait Islander children in New Zealand and Australia
There is limited evidence to direct treatment of Sydenhams chorea and clinical practice differs widely around the world Dexamethasone is an oral steroid which targets the abnormal immune response and successfully treats other immune-mediated brain disorders with good tolerability
TREAT-SC is a randomized double-blinded placebo-controlled trial which will investigate whether a three day course of oral dexamethasone safely and effectively treats the movement disorder and psychiatric symptoms of Sydenhams chorea The trial will recruit 80 participants from study sites in Australia and New Zealand
Sydenhams chorea is a condition that impacts approximately 12 of children with acute rheumatic fever It is caused by inflammation in the brain following an abnormal immune response to Group A streptococcus bacterial infection Sydenhams chorea is a movement disorder that causes childrens faces hands and feet to move quickly and uncontrollably and can also affect mood and concentration The physical recovery from Sydenhams chorea can take two to six months but the mental recovery eg mood and concentration can take longer to resolve Sydenhams chorea remains endemic in Māori Pacific Islander Aboriginal and Torres Strait Islander children in New Zealand and Australia
There is limited evidence to direct treatment of Sydenhams chorea and clinical practice differs widely around the world Dexamethasone is an oral steroid which targets the abnormal immune response and successfully treats other immune-mediated brain disorders with good tolerability
TREAT-SC is a randomized double-blinded placebo-controlled trial which will investigate whether a three day course of oral dexamethasone safely and effectively treats the movement disorder and psychiatric symptoms of Sydenhams chorea The trial will recruit 80 participants from study sites in Australia and New Zealand
Detailed Description:
Aim The aim of the trial is to determine whether an early short course of oral dexamethasone is a safe and effective treatment to reduce morbidity associated with Sydenhams chorea in New Zealand and Australian children
Objectives
The primary objective is to determine whether oral dexamethasone is an effective treatment to reduce Sydenhams chorea severity in New Zealand and Australian children at one month
The secondary objectives are to determine whether oral dexamethasone is an effective treatment to reduce Sydenhams chorea severity at different time points relapse and recurrence rates at three and 12 months total hospital length of stay at three months treatment failure at 14 days use of adjunctive chorea treatments Universidade Federal de Minas Gerais UFMG Sydenhams Chorea Rating Scale USCRS subscores and psychiatric symptoms scored by the Strengths and Difficulties Questionnaire at one three and 12 months The safety of oral dexamethasone use will be assessed at study visits on days three and seven and at one month to monitor for any adverse events which may relate to dexamethasone use
Research Design TREAT-SC is a pragmatic parallel-group double-blinded placebo-controlled 11 randomized efficacy trial comparing a three-day course of oral dexamethasone with placebo to treat Sydenhams chorea in New Zealand and Australian children TREAT-SC will be a multi-site trial with participants recruited from hospitals in New Zealand and Australia
Objectives
The primary objective is to determine whether oral dexamethasone is an effective treatment to reduce Sydenhams chorea severity in New Zealand and Australian children at one month
The secondary objectives are to determine whether oral dexamethasone is an effective treatment to reduce Sydenhams chorea severity at different time points relapse and recurrence rates at three and 12 months total hospital length of stay at three months treatment failure at 14 days use of adjunctive chorea treatments Universidade Federal de Minas Gerais UFMG Sydenhams Chorea Rating Scale USCRS subscores and psychiatric symptoms scored by the Strengths and Difficulties Questionnaire at one three and 12 months The safety of oral dexamethasone use will be assessed at study visits on days three and seven and at one month to monitor for any adverse events which may relate to dexamethasone use
Research Design TREAT-SC is a pragmatic parallel-group double-blinded placebo-controlled 11 randomized efficacy trial comparing a three-day course of oral dexamethasone with placebo to treat Sydenhams chorea in New Zealand and Australian children TREAT-SC will be a multi-site trial with participants recruited from hospitals in New Zealand and Australia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None