About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dexamethasone Oral
- Placebo
Treatment groups
Sponsors and collaborators
Starship Child Health, Te Toka Tumai Auckland
Lead sponsor
Health Research Council, New Zealand
Collaborator
Menzies School of Health Research
Collaborator