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TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
Sponsor: Starship Child Health, Te Toka Tumai Auckland
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 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.
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
Key Details
Gender
All
Age Range
4 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-06-17
Completion Date
2028-05
Last Updated
2025-06-24
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone Oral
Dexamethasone suspension (1mg/ml) 20mg/m2/day (maximum dose 24mg/day) given in three divided doses
Placebo
Matching capsules taken orally three times daily for three days
Locations (17)
Royal Darwin Hospital
Darwin, Northern Territories, Australia
KidzFirst Hospital
Auckland, New Zealand
Starship Child Health, Te Toka Tumai, Auckland
Auckland, New Zealand
Waitākere Hospital
Auckland, New Zealand
Gisborne Hospital
Gisborne, New Zealand
Waikato Hospital
Hamilton, New Zealand
Hawkes Bay Fallen Soldiers' Memorial Hospital
Hastings, New Zealand
Hutt Hospital
Lower Hutt, New Zealand
Wairarapa Hospital
Masterton, New Zealand
Taranaki Base Hospital
New Plymouth, New Zealand
Palmerston North Hospital
Palmerston North, New Zealand
Rotorua Hospital
Rotorua, New Zealand
Tauranga Hospital
Tauranga, New Zealand
Wellington Regional Hospital
Wellington, New Zealand
Whakatāne Hospital
Whakatāne, New Zealand
Whanganui Hospital
Whanganui, New Zealand
Whangārei Hospital
Whangarei, New Zealand