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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-17
SponsorStarship Child Health, Te Toka Tumai Auckland

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

80 Participants
are divided into 2 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