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NOT YET RECRUITING
NCT07830108
PHASE3

ACT4RHD is an Open-label, Randomised, Adaptive Platform Trial to Evaluate Novel and Repurposed Clinical Interventions for Patients With Acute Rheumatic Fever and Carditis. ACT4RHD Seeks to Determine Whether These Interventions Reduce RHD Severity at 6 Months.

Sponsor: Starship Child Health, Te Toka Tumai Auckland

View on ClinicalTrials.gov

Summary

The ACT4RHD trial is a multicentre, pragmatic, multi-arm, open-label adaptive platform trial addressing multiple therapeutic questions in patients with ARF and carditis. ACT4RHD aims to improve health outcomes for children and young people affected by ARF by finding treatments to reduce heart damage. The trial's Bayesian adaptive design enables multiple promising treatments to be tested at the same time. The trial will adapt by stopping treatments that are not effective sooner than traditional trials, adding new treatments as they become available, and answering research questions as soon as enough evidence has been collected. This flexibility allows researchers to identify the most effective treatments more quickly than traditional clinical trials.

Official title: ACT4RHD: Adaptive Collaborative Trial for Rheumatic Heart Disease

Key Details

Gender

All

Age Range

4 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-12

Completion Date

2036-12

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DRUG

Hydroxychloroquine (HCQ)

Hydroxychloroquine (HCQ)

OTHER

No Hydroxychloroquine (HCQ)

No Hydroxychloroquine (HCQ)

DRUG

Prednisone or Prednisolone

With or without initial pulsed Methylprednisolone / oral dexamethasone

OTHER

No corticosteroid

No corticosteroid

Locations (3)

Royal Hospital

Darwin, Northern Territory, Australia

Starship Child Health, Te Toka Tumai, Auckland

Auckland, New Zealand

KidzFirst Hospital

Auckland, New Zealand