TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
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 Sydenham's chorea. Sydenham's 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.
Sydenham's chorea is a movement disorder that causes children's faces, hands, and feet to move quickly and uncontrollably, and can also affect mood and concentration. The physical recovery from Sydenham's chorea can take two to six months but the mental recovery (e. g.
mood and concentration) can take longer to resolve. Sydenham's 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 Sydenham's 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 Sydenham's chorea. The trial will recruit 80 participants from study sites in Australia and New Zealand.
Study details:
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 Sydenham's chorea in New Zealand and Australian children. Objectives:. * The primary objective is to determine whether oral dexamethasone is an effective treatment to reduce Sydenham's 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 Sydenham's 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) Sydenham's 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, 1:1 randomized efficacy trial comparing a three-day course of oral dexamethasone with placebo to treat Sydenham's 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Sydenham's chorea of any severity diagnosed by a paediatrician or neurologist based on national ARF guidelines
- Child or adolescents aged 4 years to <18 years of age
Exclusion criteria
- Administered steroids or intravenous immunoglobulin since onset of the current Sydenham's chorea episode
- Evidence of concomitant severe, acute infection
- History of hypersensitivity to dexamethasone or its excipients
- Pregnancy
- Confirmed exposure of an unimmunised child to measles, mumps, rubella or chickenpox within the previous four weeks
- Receipt of a live vaccine within the previous four weeks
- Medical condition or treatment with medication which in the opinion of the trial investigators would make the child unsuitable for the trial
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06259006
Intervention or treatment
DRUG: Dexamethasone Oral
DRUG: Placebo
Conditions
- Rheumatic Fever
- Sydenham Chorea
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Research sites nearby
Closest Location:
Royal Darwin Hospital
Select from list below to view details:
Royal Darwin Hospital
Darwin, Northern Territories, Australia
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Who is running the clinical trial?
Starship Child Health, Te Toka Tumai Auckland
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dexamethasone
| Drug: Dexamethasone Oral |
PLACEBO_COMPARATOR: Placebo control
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Chorea severity at 1 month | Chorea severity measured using the Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale. Scores range from 0 to 108. A higher score correlates with a worse outcome. | 1 month |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Chorea severity | Chorea severity measured using the Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale. Scores range from 0 to 108. A higher score correlates with a worse outcome. | 7 days, 3 months, 12 months |
| Total hospital length of stay | Total hospital length of stay for chorea at three months | 3 months |
| Treatment failure at 14 days | Number of participants with treatment failure at 14 days | 14 days |
| Use of adjunctive chorea treatments | Number of participants treated with adjunctive chorea treatments | 1 month |
| Chorea relapse and recurrence | Number of participants with chorea relapse and recurrence at 3 and 12 months | 3 and 12 months |
| Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale Subscores. | Behaviour (0 to 24 points), Activities of Daily Living (0 to 28 points) and Motor Assessment (0-56 points). A higher score correlates with a worse outcome. | 7 days, 1 month, 3 months, 12 months |
| Psychiatric symptoms | Strength and Difficulties Questionnaire Total Difficulties Score. The resultant score ranges from 0 to 40. An abnormally high total difficulties score correlates with worse outcome. | 1 month, 3 months and 12 months |
References
Clinical Trials Gov: TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in ChildrenOther trials to consider
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