PREDICATE Trial For Respiratory Tract Infections

NCT06472219 | Recruiting Phase 3 DMC

• 1 other identifier: PREDICATE
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Tract Infections

Keywords

Emergency Care; Inflammation; Mortality; Pneumonia; Prednisolone; Randomised Controlled Trial; Respiratory Tract Infections; Safety; Sepsis; Steroids

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Maximal WHO Clinical Progression Scale(WHO-CPS)

  Up to 30-days

• Mortality

  Up to 30-days

• Sepsis

  Up to 30-days

• Length of Hospital Stay

  Up to 30-days

• Patient Satisfaction

  Up to 30-days

Study Arms (2)

Placebo + usual care

PLACEBO COMPARATOR

Placebo tablets administered once a day for five days.

Drug: Placebo

Active Treatment I + usual care

ACTIVE COMPARATOR

Prednisolone 30mg tablets administered once a day for five days.

Drug: Prednisolone 30 mg

Interventions

Prednisolone 30 mg DRUG

This 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.

Also known as: Prednisolone

Active Treatment I + usual care

Placebo DRUG

This a tablet identical to prednisolone.

Also known as: Prednis

Placebo + usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible for the study if ALL the following are present:
• 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

You may not qualify if:

• Patients will be excluded if the treating clinician considers that the patient is not suitable for the trial.
• Patients may be excluded if any ONE of the following are present:
• 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
• Undergoing active cancer therapy;
• Neutropenia due to chemotherapy/malignancy (but not due to sepsis)
• Immunocompromised or being treated with immunotherapy
• Organ transplantation
• HIV and on HIV drugs (indinavir, atazanavir, nelfinavir, saquinavir, ritonavir)
• Recent Surgery (within one month)
• Dialysis (including CAPD)
• Diabetic ketoacidosis
• Acute asthma

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

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MeSH Terms

Conditions

Respiratory Tract Infections; Inflammation; Pneumonia; Sepsis

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Systemic Inflammatory Response Syndrome

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Timothy H Rainer

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy H Rainer, MD

CONTACT

39176846; thrainer@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is double-blind study. While the study is in progress, access to tabular results of study outcomes by treatment allocation will not be available to the research team, Co-Investigators, trial statisticians, clinical teams, or members of the study coordinator (unless the Data Management Committee advises otherwise). The Data Management Committee(DMC) and DMC statisticians will be unblinded to study allocation at predetermined times.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Chairperson

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 25, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 8, 2027
• Study Completion (Estimated): December 8, 2028
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)