PREDICATE Trial For Respiratory Tract Infections

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Respiratory Tract Infections

In brief

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.

Key facts

Study ID

NCT06472219

Run by

The University of Hong Kong

People needed

1300

Starts

2024-12-23

Expected to finish

2028-12-08

Last updated by the study team

2025-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Recurrent chest infection,
• Cushing's or Addisonian's disease,
• Long term systemic steroid
• Long-term antibiotics

Where it is running

• Queen Mary Hospital — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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