PREDICATE Trial For Respiratory Tract Infections
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 parti
| Condition(s) | Respiratory Tract Infections |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 canc |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The University of Hong Kong |
| Locations | Hong Kong, Hong Kong |
| Start date | 2024-12-23 |
| NCT ID | NCT06472219 |
| Official listing | https://clinicaltrials.gov/study/NCT06472219 |