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.

ConditionsRheumatic Fever Rheumatic Heart Disease in Children Acute Rheumatic Fever Rheumatic Heart Disease

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age4-25

SponsorStarship Child Health, Te Toka Tumai Auckland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥4 and ≤25 years old

Currently admitted to hospital, or hospital like setting, with the primary diagnosis of Definite or Possible Acute Rheumatic Fever (diagnosed according to the 2015 Jones Criteria)

Echocardiographic confirmed valvulitis during the current admission

If previous participation in the randomised ACT4RHD platform, then meets pre-specified criteria for re-enrolment

Disqualifiers

Presentation to current hospital was more than 10 days prior to randomisation

Cardiac surgery (or anticipated interhospital transfer for cardiac surgery) or death is anticipated within 72 hours from screening

Patient has had cardiac intervention (surgery or percutaneous) for RHD within the last 6 months

Previous cardiac intervention /surgery for RHD more than 6months ago, but patient has not had at least 2 post-intervention echocardiograms, including at least 1 echocardiogram more than 6months after the intervention.

Trial design

Design model

Factorial

Treatments tested in this trial

Hydroxychloroquine (HCQ)
Drug
Hydroxychloroquine (HCQ)
No Hydroxychloroquine (HCQ)
Other intervention
No Hydroxychloroquine (HCQ)
Prednisone or Prednisolone
Drug
With or without initial pulsed Methylprednisolone / oral dexamethasone
No corticosteroid
Other intervention
No corticosteroid

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: Immunomodulatory DomainOther 2 interventions

Group B: Corticosteroid domainOther 2 interventions

Trial outcomes

Primary outcomes

6-point ordinal scale

The primary endpoint is a 6-point ordinal scale which comprises RHD severity (measured by echocardiography), need for rheumatic cardiac surgery or death at 6 months.

Time frame

6 months from enrolment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Starship Child Health, Te Toka Tumai Auckland

Lead sponsor

Menzies School of Health Research

Collaborator

Berry Consultants

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: