Authors (including presenting author) :
Rainer TH(1)(2), Hung IFN(1)(2), Lam PK(1)(2), Wai KCA(1)(2), Wong CKH(1), Graham CA(3)(4), Ko FWS(3)(4), Hung KKC(3)(4), Chan EWW(1), Tsang OTY(5), Ip YT(1), Lam LY(1), Yeung MHT(1), Hui DSC(3)(4)
Affiliation :
(1)The University of Hong Kong, (2)Queen Mary Hospital, (3)The Chinese University of Hong Kong, (4)Prince of Wales Hospital, (5)Princess Margaret Hospital
Introduction :
Acute Respiratory Infections are leading cause of death worldwide and in Hong Kong. The WHO has recommended that the search for effective and safe treatments through randomised controlled trials be pursued. There is a need evidence for a safe role for early treatments in patients with suspected community-acquired acute respiratory tract infections (scARIs) to reduce progression to sepsis, mortality and other outcomes.
Objectives :
In adults attending Emergency Departments (EDs) with scARI and planned hospitalisation, to determine the effect of active treatments (i.e. prednisolone) to reduce the risk of sepsis or mortality within 30 days; and to determine the safety of treatments.
Methodology :
PREDICATE is an investigator-initiated, parallel, double-blind, randomised, multi-centre, adaptive platform, controlled trial conducted in the EDs or medical wards. In adults with scARI, and planned hospitalisation receiving usual care (UC), we hypothesise a significant reduction of patients with sepsis or who die within 30 days after initiating prednisolone compared with placebo, and no significant increase in serious adverse events (SAEs).
The trial aims to recruit 1300 adult patients (650 per arm). The interventions are Placebo vs Active Treatment (i.e. prednisolone); tablets are administered by mouth once daily for five days + UC. The co-primary outcome I is the proportion of patients with either sepsis or mortality; co-primary outcome II is safety (the proportion of patients with at least one SAE); both censored at 30 days from randomisation. Secondary outcomes include WHO-CPS, mortality, sepsis, length of hospital stay, cost effectiveness and patient satisfaction. Instruments: WHO-CPS, SOFA.
Result & Outcome :
The primary analysis for the co-primary outcome I study population is Intention-to-treat (ITT) aiming for superiority and expecting a reduction from 25% to 18%. The analysis for co-primary outcome II is As-Treated (AT) aiming for non-inferiority between treatment arms. Pre-study sample sizes are refined by Bayesian analysis. Cost-effectiveness will be measured in terms of cost per quality-adjusted life year gained. A full incremental analysis will be performed. The trial has started in December 2024.
