[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461306":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":90,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The intervention (CRP-guided) group","EXPERIMENTAL","Standard usual care (following GOLD initiative, including bronchodilator, and systemic steroid).\n\nThe attending doctor will use the CRP level to inform their decision to continue antibiotics around 3 hours from blood taking. These doctors will be provided pre-study training on CRP interpretation.\n\nEvery day from randomization, serum CRP testing will be encouraged to take. Once CRP has declined to \\\u003C5mg\u002FdL and the patient has remained afebrile for past 48 hours, antibiotic treatment will be reviewed for discontinuation. Otherwise, antibiotic treatment will be continued. A switch on the administration route, or a change of antibiotics due to adverse effect, allergy, or suggestion from culture result, is permitted according to in-patient physician's decisions. CRP will continue to be monitored daily upon discharge from that hospital (up to 28 days).",[13],"Procedure: The intervention (CRP-guided) group",{"label":15,"type":16,"description":17,"interventionNames":18},"The usual care (control) group","NO_INTERVENTION","Patients in the control arm will be treated with usual care (GOLD initiative). No CRP would be measured.No CRP would be measured.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","The attending doctor will use the CRP level to inform their decision to continue antibiotics around 3 hours from blood taking. These doctors will be provided pre-study training on CRP interpretation.\n\nEvery day from randomization, serum CRP testing will be encouraged to take. Once CRP has declined to \\\u003C5mg\u002FdL and the patient has remained afebrile for past 48 hours, antibiotic treatment will be reviewed for discontinuation. Otherwise, antibiotic treatment will be continued. A switch on the administration route, or a change of antibiotics due to adverse effect, allergy, or suggestion from culture result, is permitted according to in-patient physician's decisions. CRP will continue to be monitored daily upon discharge from that hospital (up to 28 days).",[9],[25],{"name":26,"affiliation":5,"role":27},"Ka Chung Abraham WAI","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","(+852) 3917 9859","awai@hku.hk",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Shi Yeow LEE","(+852) 9474 4035","shiyeow@hku.hk",[38],{"facility":39,"status":18,"city":40,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Queen Mary Hospital","Hong Kong","HK",{"type":43,"coordinates":44},"Point",[45,46],114.17469,22.27832,{"lat":46,"lon":45},[49,51,52],{"name":50,"role":30,"phone":18,"phoneExt":18,"email":18},"Ka Chung Abraham Wai, MBChB(CUHK)",{"name":50,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":53,"role":54,"phone":18,"phoneExt":18,"email":18},"Timothy H RAINER, BSc, MBBCh","SUB_INVESTIGATOR",{"type":27,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Dr. Wai, Ka Chung Abraham","Clinical Assistant Professor",[59],{"name":60,"class":61},"Food and Health Bureau, Hong Kong","OTHER_GOV","100461306","antibiotic-stewardship-in-aecopd-through-crp-guided-management-100461306",false,"NCT05286918","Antibiotic Stewardship in AECOPD Through CRP-Guided Management","Antibiotic Stewardship Through CRP-guided Antibiotic Treatment for Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)","Inclusion Criteria:\n\n1. Being diagnosed with active AECOPD (AECOPD is defined as an event in the natural course of a disease characterized by a change in baseline dyspnoea, cough, and\u002For sputum that is beyond the normal day-to-day variations with acute onset, which may warrant a change in regular medication in patients with underlying COPD).\n2. Known COPD in their medical records.\n3. Age 40 years or older.\n4. Able to provide informed consent in Cantonese, Mandarin, or English\n5. Able to complete the questionnaires during the study period (i.e. 6 months after randomisation)\n\nExclusion Criteria:\n\nPatients will be excluded if any ONE of the following are present:\n\n1. Pre-treatment with systemic corticosteroids for the present exacerbation.\n2. Pre-treatment with any antibiotics for the present exacerbation, any concurrent infection or prophylaxis.\n3. Known clinical stroke in past 6 months\n4. Patients with high suspicion of active AECOPD mimics:\n\n   1. Pneumonia\n   2. Congestive heart failure\n   3. Bronchiectasis\n   4. Pulmonary embolism\n   5. Pneumothorax\n   6. Atrial fibrillation \u002F flutter\n5. Lung comorbidities:\n\n   1. Cystic fibrosis\n   2. Tuberculosis\n   3. Unresolved lung malignancy\n6. Progression or new radiographic abnormalities on the chest X-ray.\n7. Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs for more than 28 days.\n8. Active inflammatory condition (e.g. flare up of rheumatoid arthritis, gout or polymyalgia rheumatica) or concurrent infection at another site (e.g. UTI, cellulitis) that is likely to produce a systemic response\n9. Currently pregnant\n10. NEWS2 score of ≥3","ALL","40 Years",{"count":72,"type":73},1184,"ESTIMATED","INTERVENTIONAL",[76],"NA","Objectives:\n\nTo determine whether CRP-guided antibiotic treatment for managing AECOPD in adult patients attending Emergency Departments leads to reduced antibiotic duration, without non-inferior COPD health status with usual care.\n\nHypothesis to be tested:\n\n(i) The antibiotic duration in AECOPD patients will be significantly lower for CRP-guided antibiotic discontinuation than usual care; and (ii) COPD health status as measured by the Clinical COPD Questionnaire has no statistically significant difference between two groups.\n\nDesign and subjects:\n\nMulti-center, single-blind, open-label, randomized, combined superiority (antibiotic duration) and non-inferiority (COPD health status) trial in 1,184 adult AECOPD patients presented to A\\&E.\n\nInstruments:\n\nClinical COPD Questionnaire and EuroQol-5D\n\nInterventions:\n\nBoth intervention and control groups follow usual care with GOLD strategy. The intervention group will be recommended to test for serum CRP daily. Antibiotic prescription is considered when CRP \\>5mg\u002FdL. Once CRP has declined to \\\u003C5mg\u002FdL and the patient was afebrile for past 48 hours, antibiotic discontinuation will be considered.\n\nCommunication with Receiving Ward Staffs:\n\nParticipants in the study may transfer to another departments after treatment\u002F care in A\\&E. The following communication would be conducted:\n\n* A handover note that informs the receiving ward staffs about patients' enrolment to the trial, group assignment, and previous treatments given in A\\&E. The note would also suggest the investigations for the receiving ward staffs.\n* Telephone handover about intervention group and investigations of the study, and treatments given in A\\&E to ward.\n\nMain outcome measures:\n\nThe antibiotic duration (total number of antibiotic days) within 28 days and recovery in terms of COPD health status (Clinical COPD Questionnaire total scores) within 14 days from randomisation.\n\nData analysis:\n\nIntention-to-treat and cost-effectiveness analyses will be performed. The outcome assessors and data analysts will be blinded to group allocation.\n\nExpected results:\n\nThe intervention group will exhibit reduction in antibiotic duration at 4-weeks, without negatively impacting on COPD health status, compared with the control group.",[79,80,81,82,83],"Acute Exacerbation of COPD","Lung Diseases","Lung Diseases, Obstructive","Pulmonary Disease, Chronic Obstructive","Respiratory Tract Disease",[85,86,87,88,89],"COPD","Antibiotics","C-Reactive Protein","Antibiotic stewardship","Emergency Department","NOT_YET_RECRUITING","2022-05-16",{"date":93,"type":94},"2022-05-23","ACTUAL",{"date":96,"type":73},"2022-09-01",{"date":98,"type":73},"2026-08-31",{"name":5,"class":6},1]