[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552371":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":68,"collaborators":43,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":43,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":43,"enrollmentInfo":80,"targetDuration":43,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo + usual care","PLACEBO_COMPARATOR","Placebo tablets administered once a day for five days.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Treatment I + usual care","ACTIVE_COMPARATOR","Prednisolone 30mg tablets administered once a day for five days.",[19],"Drug: Prednisolone 30 mg",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Prednisolone 30 mg","This is a glucocorticoid like cortisol used for its anti-inflammatory, immunosuppressive, anti-neoplastic and vasoconstrictive effects. It binds to the glucocorticoid receptor, inhibiting pro-inflammatory signals and promoting anti-inflammatory signals. It has a short duration of action as the half-life is 2.1-3.5 hours and 98% is eliminated in urine. On 21 June 1955 it was granted FDA approval.",[15],[27],"Prednisolone",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","This a tablet identical to prednisolone.",[9],[33],"Prednis",[35],{"name":36,"affiliation":5,"role":37},"Timothy H Rainer","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Timothy H Rainer, MD","CONTACT","39176846",null,"thrainer@hku.hk",[46],{"facility":47,"status":48,"city":49,"state":43,"zip":43,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Queen Mary Hospital","RECRUITING","Hong Kong","HK",{"type":52,"coordinates":53},"Point",[54,55],114.17469,22.27832,{"lat":55,"lon":54},[58,62,66],{"name":59,"role":41,"phone":60,"phoneExt":43,"email":61},"Miffy Hudson Lam, Bachelor","+852-55063028","lly201@hku.hk",{"name":63,"role":41,"phone":64,"phoneExt":43,"email":65},"Carrie Ip, Bachelor","+852-97360869","ipcarrie@hku.hk",{"name":67,"role":37,"phone":43,"phoneExt":43,"email":43},"Timothy Hudson Rainer, Clinical Professor",{"type":37,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Prof. Timothy Hudson RAINER","Clinical Professor and Chairperson","100552371","phase-3-predicate-trial-for-respiratory-tract-infections-100552371",false,"NCT06472219","PREDICATE Trial For Respiratory Tract Infections","Early Prednisolone for Suspected Community-acquired Acute Respiratory Tract Infection (PREDICATE): A Double-blind, Randomised, Multi-centre, Adaptive Platform, Controlled Trial","Inclusion Criteria:\n\nPatients will be eligible for the study if ALL the following are present:\n\n1. Adults ≥18 years of age; AND\n2. scARI; AND\n3. Intended hospitalisation; AND\n4. No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he\u002Fshe were to participate in the trial\n\nExclusion Criteria:\n\nPatients will be excluded if the treating clinician considers that the patient is not suitable for the trial.\n\nPatients may be excluded if any ONE of the following are present:\n\n1. Vulnerable subjects (pregnancy; cognitively impaired; prisoners; students; umemployee; minorities);\n2. Cardiac arrest or post-cardiac arrest ROSC;\n3. Not expected to survive 3 days due to pre-existing chronic disease;\n4. Palliative (comfort) care\n5. Undergoing active cancer therapy;\n6. Neutropenia due to chemotherapy\u002Fmalignancy (but not due to sepsis)\n7. Immunocompromised or being treated with immunotherapy\n8. Organ transplantation\n9. HIV and on HIV drugs (indinavir, atazanavir, nelfinavir, saquinavir, ritonavir)\n10. Recent Surgery (within one month)\n11. Dialysis (including CAPD)\n12. Diabetic ketoacidosis\n13. Acute asthma\n14. Recurrent chest infection,\n15. Cushing's or Addisonian's disease,\n16. Long term systemic steroid\n17. Long-term antibiotics","ALL","18 Years",{"count":81,"type":82},1300,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","Background\n\nThe 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:\n\nDoes 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.\n\nParticipants will:\n\nTake 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 of hospitals in Hong Kong.\n\nInvestigators expect the proportion of patients admitted to the hospital who develop sepsis or who die within 30 days to be reduced from 25% to 18% after taking active treatment. Secondly, investigators expect any difference in the proportion of patients with Serious adverse events(SAEs) not to exceed 5% between active treatment group and control.\n\nBenefits to Hong Kong and Worldwide: Active treatments (e.g. prednisolone are cheap, HK$0.2 per 5mg tablet) are widely available across the world. Any reduction of progression to sepsis and death if applied worldwide would improve the lives of millions of patients and save millions of dollars of healthcare costs.",[88],"Respiratory Tract Infections",[90,91,92,93,27,94,88,95,96,97],"Emergency Care","Inflammation","Mortality","Pneumonia","Randomised Controlled Trial","Safety","Sepsis","Steroids","2025-01-13",{"date":100,"type":101},"2025-01-15","ACTUAL",{"date":103,"type":101},"2024-12-23",{"date":105,"type":82},"2028-12-08",{"name":5,"class":6},1]