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TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children

PHASE3NOT_YET_RECRUITING

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.

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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.

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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

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Eligibility

Age eligible for study : 4 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-05-01

Primary completion: 2027-05-01

Study completion finish: 2028-05-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06259006

Intervention or treatment

DRUG: Dexamethasone Oral

DRUG: Placebo

Conditions

• Rheumatic Fever
• Sydenham Chorea

Condition: Rheumatic Fever, Sydenham Chorea
DRUG: Dexamethasone Oral and other drugs
Darwin, Northern Territories, Australia
Sponsor: Starship Child Health, Te Toka Tumai Auckland

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Find a site

Closest Location:

Royal Darwin Hospital

Research sites nearby

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Royal Darwin Hospital
Darwin, Northern Territories, Australia

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 Participants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days	DRUG: Dexamethasone Oral 4mg capsules taken orally in three divided doses to a total daily dose of 20mg/m2 (maximum dose 24mg/day) for three days
PLACEBO_COMPARATOR: Placebo control Participants will receive oral placebo tablet three times a day for 3 days	DRUG: Placebo Matching capsules taken orally three times daily for three days

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Adverse events	Frequency of adverse events	3 days, 7 days, 1 month
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

Frequently Asked Questions

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References

Clinical Trials Gov: TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children