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PREDICATE Trial For Respiratory Tract Infections

RecruitingPhase 3Ages 18 Years - anyAllThe University of Hong Kong
NCT06472219 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Prednisolone 30 mg
  • Placebo
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Where

1 site
Queen Mary Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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