A Phase 3 interventional study of Dexamethasone Oral and Placebo in Rheumatic Fever and Sydenham Chorea, sponsored by Starship Child Health, Te Toka Tumai Auckland. Recruiting at 17 sites in 2 countries. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Starship Child Health, Te Toka Tumai Auckland · Phase 3, Interventional, and Treatment
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.
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:
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.
55 studies on the registry are indexed under Rheumatic Fever; 21 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 28 interventional studies indexed under Rheumatic Fever.
Browse Rheumatic Fever studies →Starship Child Health, Te Toka Tumai Auckland is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days
Drug: Dexamethasone Oral
Participants will receive oral placebo tablet three times a day for 3 days
Drug: Placebo
Dexamethasone suspension (1mg/ml) 20mg/m2/day (maximum dose 24mg/day) given in three divided doses
Matching capsules taken orally three times daily for three days
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.
Time frame: 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.
Time frame: 7 days, 3 months, 12 months
Total hospital length of stay
Total hospital length of stay for chorea at three months
Time frame: 3 months
Treatment failure at 14 days
Number of participants with treatment failure at 14 days
Time frame: 14 days
Use of adjunctive chorea treatments
Number of participants treated with adjunctive chorea treatments
Time frame: 1 month
Chorea relapse and recurrence
Number of participants with chorea relapse and recurrence at 3 and 12 months
Time frame: 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.
Time frame: 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.
Time frame: 1 month, 3 months and 12 months
Plan to share: No — De-identified data would be shared with researchers conducting meta-analysis study if robust research plan is provided and request emailed to PI.
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for May 2027, 35 months after the start.
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Studies of the drug tested here: Dexamethasone
Starship Child Health, Te Toka Tumai Auckland