PREDICATE Trial For Respiratory Tract Infections
NCT Number: NCT06472219
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Respiratory Tract Infections
Interventions: DRUG: Prednisolone 30 mg|DRUG: Placebo
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-07-31

Summary:
Background

The goal of this clinical trial is to learn if prednisolone works to treat moderate to severe respiratory tract infections in adults admitted to hospital. It will also learn about the safety of prednisolone in this context. The main questions it aims to answer are:

Does prednisolone lower the number of participants who develop sepsis or who survive? What medical problems do participants have when taking prednisolone? Researchers will compare prednisolone to a placebo (a look-alike substance that contains no drug) to see if prednisolone works to treat respiratory tract infections in adults.

Participants will:

Take prednisolone 30mg or a placebo every day for 5 days. Complete a daily diary of symptoms for 30 days and have telephone follow up. Investigators propose to recruit 1300 patients, 650 in each group. The Trial will be conducted in the Emergency Departments and wards of hospitals in Hong Kong.

Investigators expect the proportion of patients admitted to the hospital who develop sepsis or who die within 30 days to be reduced from 25% to 18% after taking active treatment. Secondly, investigators expect any difference in the proportion of patients with Serious adverse events(SAEs) not to exceed 5% between active treatment group and control.

Benefits to Hong Kong and Worldwide: Active treatments (e.g. prednisolone are cheap, HK$0.2 per 5mg tablet) are widely available across the world. Any reduction of progression to sepsis and death if applied worldwide would improve the lives of millions of patients and save millions of dollars of healthcare costs.

Primary Outcome Measures: 30-day all-cause sepsis or all-cause mortality, The proportion of patients with all-cause sepsis or all-cause mortality, Up to 30-days|30-day Severe Adverse Events, The proportion of patients with an SAE, Up to 30-days
Secondary Outcome Measures: Maximal WHO Clinical Progression Scale(WHO-CPS), Differentiation of median maximal WHO-CPS hospitalised patients with scARI. \[0 - not infected\] Ambulatory mild disease

1. Not hospitalised, asymptomatic, no limitation on activities, virus detected;
2. Not hospitalised, symptomatic, independent
3. Not hospitalised, limitation on activities, assistance required; Hospitalised moderate disease
4. Hospitalised, not requiring supplemental oxygen;
5. Hospitalised, requiring supplemental oxygen; Hospitalised severe disease
6. Hospitalised, on oxygen by Non-invasive ventilation(NIV) or high flow;
7. Hospitalised, intubation and mechanical ventilation
8. Hospitalised, mechanical ventilation or vasopressors
9. Hospitalised, mechanical ventilation, vasopressors, dialysis or Extracorporeal membrane oxygenation(ECMO);
10. Death., Up to 30-days|Mortality, The proportion of patients with mortality, Up to 30-days|Sepsis, The proportion of patients with sepsis, Up to 30-days|Length of Hospital Stay, Differentiation of median length of stay, Up to 30-days|Patient Satisfaction, Differentiation of median patient satisfaction score \[Score:0 - 10\], Up to 30-days|Cost-effectiveness analysis, Cost-effectiveness comparison between the two groups. • Cost-effectiveness analysis measure is the total cost difference between treatment group and placebo group divided by total Quality-adjusted life year(QALY) difference between treatment group and placebo group;

• Total cost difference between treatment group and placebo group divided by difference in primary and secondary outcomes between treatment group and placebo group, 30-days