PREDICATE Trial For Respiratory Tract Infections
ConditionRespiratory Tract Infections
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18 years of age; AND
scARI; AND
Intended hospitalisation; AND
No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial
Disqualifiers
Vulnerable subjects (pregnancy; cognitively impaired; prisoners; students; umemployee; minorities);
Cardiac arrest or post-cardiac arrest ROSC;
Not expected to survive 3 days due to pre-existing chronic disease;
Palliative (comfort) care
Trial design
Design model
Parallel
Treatments tested in this trial
Prednisolone 30 mg
DrugThis is a glucocorticoid like cortisol used for its anti-inflammatory, immunosuppressive, anti-neoplastic and vasoconstrictive effects. It binds to the glucocorticoid receptor, inhibiting pro-inflammatory signals and promoting anti-inflammatory signals. It has a short duration of action as the half-life is 2.1-3.5 hours and 98% is eliminated in urine. On 21 June 1955 it was granted FDA approval.
Placebo
DrugThis a tablet identical to prednisolone.
Treatment groups
1,300 Participants
are divided into 2 treatment groupsGroup A: Placebo + usual carePlacebo comparator 1 intervention
Group B: Active Treatment I + usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-day all-cause sepsis or all-cause mortality
The proportion of patients with all-cause sepsis or all-cause mortality
Time frame
Up to 30-days2
30-day Severe Adverse Events
The proportion of patients with an SAE
Time frame
Up to 30-daysSecondary outcomes
1
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.
Time frame
Up to 30-days2
Mortality
The proportion of patients with mortality
Time frame
Up to 30-days3
Sepsis
The proportion of patients with sepsis
Time frame
Up to 30-days4
Length of Hospital Stay
Differentiation of median length of stay
Time frame
Up to 30-daysSponsors and contacts
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Source ClinicalTrials.gov