Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Using prednisolone to treat respiratory tract infections in hospitalized adults

Official title: Early Prednisolone for Suspected Community-acquired Acute Respiratory Tract Infection (PREDICATE): A Double-blind, Randomised, Multi-centre, Adaptive Platform, Controlled Trial

Run by The University of Hong Kong · NCT06472219 · Data updated 2026-11-12

This study is testing if giving prednisolone to hospitalized adults with moderate to severe respiratory infections can help them recover better and avoid serious complications.

More Respiratory Tract Infections trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1300 (estimated)
SponsorThe University of Hong Kong
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Hong Kong)
StatusRecruiting
StartedDecember 23, 2024
Main results expectedDecember 8, 2027
Study endsDecember 8, 2028
Registry record updatedJanuary 15, 2025
Trial IDNCT06472219 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who are hospitalized with moderate to severe acute respiratory infections.

Probably not a fit

Patients who are in palliative care, have severe pre-existing conditions, or are undergoing active cancer therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of prednisolone in treating moderate to severe respiratory tract infections in adults who are hospitalized. Participants will receive either prednisolone 30 mg or a placebo daily for five days, and their symptoms will be monitored through daily diaries and follow-up calls over 30 days. The study will compare the outcomes between the two groups, focusing on the incidence of sepsis and overall survival rates. A total of 1300 patients will be recruited from emergency departments and wards in Hong Kong.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality and complications associated with respiratory tract infections.

How similar studies have gone: Previous studies have shown promise in using corticosteroids for respiratory infections, but this specific approach with prednisolone is being evaluated for the first time in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

1. Adults ≥18 years of age; AND
2. scARI; AND
3. Intended hospitalisation; AND
4. 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

Exclusion Criteria:

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:

1. Vulnerable subjects (pregnancy; cognitively impaired; prisoners; students; umemployee; minorities);
2. Cardiac arrest or post-cardiac arrest ROSC;
3. Not expected to survive 3 days due to pre-existing chronic disease;
4. Palliative (comfort) care
5. Undergoing active cancer therapy;
6. Neutropenia due to chemotherapy/malignancy (but not due to sepsis)
7. Immunocompromised or being treated with immunotherapy
8. Organ transplantation
9. HIV and on HIV drugs (indinavir, atazanavir, nelfinavir, saquinavir, ritonavir)
10. Recent Surgery (within one month)
11. Dialysis (including CAPD)
12. Diabetic ketoacidosis
13. Acute asthma
14. Recurrent chest infection,
15. Cushing's or Addisonian's disease,
16. Long term systemic steroid
17. Long-term antibiotics

Where it's running

  • Queen Mary Hospital
    Hong Kong, Hong Kong
    Recruiting

Study contacts

  • Principal investigator: Timothy H Rainer — The University of Hong Kong
  • Study coordinator: Timothy H Rainer, MD
  • Email: thrainer@hku.hk
  • Phone: 39176846

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.