Using prednisolone to treat respiratory tract infections in hospitalized adults
Early Prednisolone for Suspected Community-acquired Acute Respiratory Tract Infection (PREDICATE): A Double-blind, Randomised, Multi-centre, Adaptive Platform, Controlled Trial
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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06472219 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are hospitalized with moderate to severe acute respiratory infections.
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.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and complications associated with respiratory tract infections.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.