Early three-day oral dexamethasone for Sydenham chorea in children

TREAT-SC: A Randomised, Double-Blinded, Placebo-Controlled Trial of Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children

We will try a three-day course of oral dexamethasone to see if it helps children aged 4–17 recover faster and feel better from Sydenham chorea.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 4 Years to 17 Years
• Sex: All
• Sponsor: Starship Child Health, Te Toka Tumai Auckland (Government)
• Locations: 17 sites (Darwin, Northern Territories and 16 other locations)
• Trial ID: NCT06259006 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial compares a three-day course of oral dexamethasone with placebo in a 1:1 allocation among children with Sydenham chorea in New Zealand and Australia. Participants aged 4 to under 18 years are recruited at multiple hospitals and followed at days 3 and 7 and at one, three and 12 months to measure motor severity, psychiatric symptoms, relapse and safety. The primary outcome is chorea severity at one month, with secondary outcomes including recurrence, hospital length of stay, adjunctive treatments, motor and psychiatric subscores, and treatment failure at 14 days. Safety monitoring focuses on adverse events potentially related to short-course dexamethasone during the early post-treatment period.

Who should consider this trial

Good fit: Ideal candidates are children aged 4 to under 18 years with a paediatrician- or neurologist-diagnosed Sydenham chorea who have not received steroids or intravenous immunoglobulin for the current episode.

Not a fit: Children who have already received steroids or IVIG for the current episode, have severe acute infection, recent live vaccination or exposure, pregnancy, known dexamethasone hypersensitivity, or other medical reasons deemed unsuitable are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, a short early steroid course could shorten physical and mental recovery, reduce symptom severity and hospital stays, and decrease the need for longer-term therapies.

How similar studies have performed: There is limited randomized evidence and existing support comes mainly from small case series and observational reports suggesting steroids may help, so randomized data are still lacking.

Eligibility criteria

Inclusion Criteria:

1. Sydenham's chorea of any severity diagnosed by a paediatrician or neurologist based on national ARF guidelines
2. Child or adolescents aged 4 years to \<18 years of age

Exclusion Criteria:

1. Administered steroids or intravenous immunoglobulin since onset of the current Sydenham's chorea episode
2. Evidence of concomitant severe, acute infection
3. History of hypersensitivity to dexamethasone or its excipients
4. Pregnancy
5. Confirmed exposure of an unimmunised child to measles, mumps, rubella or chickenpox within the previous four weeks
6. Receipt of a live vaccine within the previous four weeks
7. Medical condition or treatment with medication which in the opinion of the trial investigators would make the child unsuitable for the trial

Where this trial is running

Darwin, Northern Territories and 16 other locations

• Royal Darwin Hospital — Darwin, Northern Territories, Australia (Recruiting)
• KidzFirst Hospital — Auckland, New Zealand (Recruiting)
• Starship Child Health, Te Toka Tumai, Auckland — Auckland, New Zealand (Recruiting)
• Waitākere Hospital — Auckland, New Zealand (Recruiting)
• Gisborne Hospital — Gisborne, New Zealand (Recruiting)
• Waikato Hospital — Hamilton, New Zealand (Recruiting)
• Hawkes Bay Fallen Soldiers' Memorial Hospital — Hastings, New Zealand (Recruiting)
• Hutt Hospital — Lower Hutt, New Zealand (Recruiting)
• Wairarapa Hospital — Masterton, New Zealand (Recruiting)
• Taranaki Base Hospital — New Plymouth, New Zealand (Recruiting)
• Palmerston North Hospital — Palmerston North, New Zealand (Recruiting)
• Rotorua Hospital — Rotorua, New Zealand (Recruiting)
• Tauranga Hospital — Tauranga, New Zealand (Recruiting)
• Wellington Regional Hospital — Wellington, New Zealand (Recruiting)
• Whakatāne Hospital — Whakatāne, New Zealand (Recruiting)
• Whanganui Hospital — Whanganui, New Zealand (Recruiting)
• Whangārei Hospital — Whangarei, New Zealand (Recruiting)

Study contacts

• Principal investigator: Hannah F Jones, MBChB PhD — Starship Child Health, Te Whatu Ora Health New Zealand
• Study coordinator: Hannah F Jones, MBChB PhD

Conditions Rheumatic Fever; Sydenham Chorea