PREDICATE Trial For Respiratory Tract Infections

Launched by THE UNIVERSITY OF HONG KONG · Jun 21, 2024

Keywords

ClinConnect Summary

The PREDICATE Trial is a research study aimed at understanding how well a medication called prednisolone can help treat moderate to severe respiratory tract infections in adults who are hospitalized. The main goal is to see if taking prednisolone can reduce the number of patients who develop serious complications like sepsis (a life-threatening infection) or even die within 30 days of treatment. Researchers will compare the effects of prednisolone with a placebo, which looks like the medication but contains no active ingredients, to find out if prednisolone truly makes a difference.

To participate, individuals must be at least 18 years old and have a specific type of respiratory infection that requires hospitalization. Participants will take either prednisolone or the placebo daily for five days and will keep a diary to track their symptoms for a month. The study aims to enroll 1,300 patients across hospitals in Hong Kong, and researchers hope that the findings could lead to significant improvements in treating respiratory infections worldwide, benefiting many patients and potentially reducing healthcare costs.

Gender

ALL

Eligibility 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