[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647317":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":50,"studyPopulation":41,"armGroups":51,"interventions":64,"overallOfficials":72,"centralContacts":76,"locations":81,"responsibleParty":97,"collaborators":41,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":41,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":125,"whyStopped":41,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Capital Development Authority (CDA)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Success at Day 30","Number and proportion of participants with clinical success at Day 30 (±3 days) after randomisation, compared between arms as a risk difference (7-day minus 14-day) with a non-inferiority margin of -10 percentage points. Clinical success requires all of: (a) resolution or substantial improvement of the exacerbation-related signs and symptoms present at baseline (dyspnoea, sputum volume and sputum purulence), judged by the blinded outcome assessor using predefined criteria, with a reduction of at least 2 points from baseline in the COPD Assessment Test score; (b) no additional or alternative systemic antibiotic for a respiratory indication after the allocated course, and no extension of the course because of lack of improvement; (c) no hospital readmission or emergency department visit for AECOPD; and (d) the participant is alive. Participants who do not meet all four criteria are classified as clinical failures.","Day 30 (±3 days) after randomisation",[14,18,22,25,28,31,35,38],{"measure":15,"description":16,"timeFrame":17},"Clinical Success at Day 14","Number and proportion of participants with clinical success at Day 14 (±2 days) after randomisation, defined as for the primary outcome, compared between arms as a risk difference.","Day 14 (±2 days) after randomisation",{"measure":19,"description":20,"timeFrame":21},"Time to Resolution of Exacerbation Symptoms","Number of days from randomisation to resolution of the exacerbation symptoms present at baseline.","From randomisation up to Day 30",{"measure":23,"description":24,"timeFrame":21},"Incidence of Antibiotic-Related Adverse Events and Serious Adverse Events","Number of participants with at least one adverse event or serious adverse event related to antibiotic treatment.",{"measure":26,"description":27,"timeFrame":21},"Treatment Failure","Number of participants with treatment failure, defined as the need for additional or alternative systemic antibiotics because of clinical deterioration or lack of improvement, escalation to non-invasive or invasive ventilation or intensive care after Day 3, or death.",{"measure":29,"description":30,"timeFrame":21},"Relapse","Number of participants with a new or worsening exacerbation requiring systemic antibiotics or corticosteroids after initial clinical improvement.",{"measure":32,"description":33,"timeFrame":34},"Rehospitalisation for Any Cause and for AECOPD","Number of participants readmitted to hospital, reported separately for any cause and for acute exacerbation of COPD.","Within 30 days after randomisation",{"measure":36,"description":37,"timeFrame":34},"All-Cause Mortality","Number of participants who die from any cause.",{"measure":39,"description":40,"timeFrame":21},"Total Antibiotic Consumption","Total systemic antibiotic consumption per participant, expressed in defined daily doses (DDD).",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Two-arm, parallel-group, randomised non-inferiority trial. Participants are allocated 1:1 to a 7-day or 14-day antibiotic course and followed for 30 days.","HEALTH_SERVICES_RESEARCH",{"masking":48,"maskingDescription":49,"whoMasked":41},"NONE","The trial statistician is also masked to treatment allocation, working with coded arm labels until the statistical analysis plan is finalised and the database is locked. Participants and treating clinicians are not masked because the two antibiotic courses differ in length.","Background: Antibiotics are routinely given to adults hospitalised with an acute exacerbation of COPD (AECOPD). International guidance (GOLD) advises that treatment should normally last about 5 days, but in many hospitals in Pakistan courses of 14 days remain usual practice. Longer courses increase antibiotic exposure, adverse effects and the risk of antimicrobial resistance, yet there is no randomised evidence from Pakistan on whether a shorter course is as effective for hospitalised patients.\n\nIntervention: The experimental arm receives a 7-day systemic antibiotic course and the active comparator arm the conventional 14-day course. The treating physician chooses the agent, dose and route according to institutional practice and available microbiology, so only the planned duration differs between arms. Duration is counted from the first antibiotic dose for the current exacerbation. All other care, including bronchodilators, corticosteroids, oxygen and ventilatory support, follows usual practice in both arms. The intervention was developed through a three-round Delphi consensus process with prescribers before the trial began.\n\nProcedures: Blood and sputum samples are taken at baseline for culture and susceptibility testing; results may guide a change of agent but do not change the allocated duration. Participants are assessed during treatment (Day 3-5), at Day 7, at Day 14 and at Day 30, in hospital or by telephone. Allocation uses a computer-generated sequence with permuted blocks of variable size, concealed through a web-based randomisation system.\n\nSample size: Assuming 80% clinical success in both arms, a non-inferiority margin of 10 percentage points, a one-sided alpha of 0.025 and 80% power, 252 evaluable participants per arm are required; allowing for 10% attrition, 560 participants will be enrolled.\n\nAnalysis: The primary analysis estimates the risk difference in clinical success at Day 30 (7-day minus 14-day) with a two-sided 95% Miettinen-Nurminen confidence interval. Non-inferiority will be concluded only if the lower confidence limit exceeds -10 percentage points in both the intention-to-treat and per-protocol populations. Full details are given in the study protocol (version 2.0) and statistical analysis plan (version 1.1).",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"7-day antibiotic course","EXPERIMENTAL","Participants receive systemic antibiotic therapy for a total of 7 days, counted from the first dose for the current exacerbation. The treating physician chooses the antibiotic agent, dose and route; all other care follows usual practice.",[57],"Drug: 7-day antibiotic course",{"label":59,"type":60,"description":61,"interventionNames":62},"14-day antibiotic course","ACTIVE_COMPARATOR","Participants receive systemic antibiotic therapy for a total of 14 days, counted from the first dose for the current exacerbation, which is the usual practice at the study hospital. The treating physician chooses the antibiotic agent, dose and route; all other care follows usual practice.",[63],"Drug: 14-day antibiotic course",[65,69],{"type":66,"name":53,"description":67,"armGroupLabels":68,"otherNames":41},"DRUG","Systemic antibiotic therapy is given for a total of 7 days, counted from the first dose for the current exacerbation. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the comparator.",[53],{"type":66,"name":59,"description":70,"armGroupLabels":71,"otherNames":41},"Systemic antibiotic therapy given for a total of 14 days, counted from the first dose for the current exacerbation, which is usual practice at the study hospital. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the experimental arm.",[59],[73],{"name":74,"affiliation":5,"role":75},"Fazal Rabbi, MD","PRINCIPAL_INVESTIGATOR",[77],{"name":74,"role":78,"phone":79,"phoneExt":41,"email":80},"CONTACT","+923035646227","faiz@bjmu.edu.cn",[82],{"facility":83,"status":41,"city":84,"state":85,"zip":86,"country":85,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"CDA Hospital Islamabad","Islamabad","Pakistan","44000","PK",{"type":89,"coordinates":90},"Point",[91,92],73.04329,33.72148,{"lat":92,"lon":91},[95],{"name":96,"role":78,"phone":79,"phoneExt":41,"email":80},"Dr Fazal Rabbi",{"type":75,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Fazal Rabbi","Assistant Professor","100647317","evaluating-customized-antibiotic-duration-cda-strategy-in-acute-exacerbations-of-copd-100647317",false,"NCT07708337","Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD","Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD: Protocol for Randomized Controlled Trial","CDA","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Physician-diagnosed COPD, confirmed by post-bronchodilator spirometry (FEV1\u002FFVC \\\u003C 0.70) where available, or by documented previous spirometry consistent with COPD.\n* A current acute exacerbation of COPD for which the treating physician judges antibiotic therapy to be necessary, with at least two of the three cardinal symptoms (increased dyspnoea, increased sputum volume, increased sputum purulence).\n* Able and willing to give written informed consent and to follow the study procedures and follow-up schedule.\n\nExclusion Criteria:\n\n* A documented infection that requires a defined, longer antibiotic course, such as pneumonia with complications, an exacerbation of bronchiectasis, lung abscess or empyema.\n* Need for immediate admission to intensive care or for invasive mechanical ventilation at presentation.\n* Severe immunosuppression, for example neutropenia, active malignancy under chemotherapy, organ transplantation or advanced HIV infection.\n* Suspected or confirmed pulmonary tuberculosis, or another respiratory infection that needs a different antimicrobial approach.\n* Pregnancy or breastfeeding.\n* Previous enrolment in this trial, or current participation in another interventional trial in AECOPD.\n* Systemic antibiotic treatment for the current exacerbation started more than 48 hours before randomisation.","ALL","18 Years","90 Years",{"count":112,"type":113},560,"ESTIMATED","INTERVENTIONAL",[116],"NA","The goal of this clinical trial is to learn whether a shorter course of antibiotics (7 days) works as well as the usual longer course (14 days) for adults admitted to hospital with a flare-up of chronic obstructive pulmonary disease (COPD), a long-term lung disease. The trial takes place at CDA Hospital Islamabad, Pakistan.\n\nThe main questions it aims to answer are:\n\n* Do patients who take antibiotics for 7 days recover as well by Day 30 as patients who take them for 14 days?\n* Does the shorter course lead to fewer side effects and less antibiotic use, without more treatment failures, relapses or hospital readmissions? Researchers will compare a 7-day antibiotic course with the usual 14-day course to see if the shorter course is just as effective.\n\nParticipants will:\n\n* Be assigned by chance (like flipping a coin) to take antibiotics for either 7 days or 14 days. Their doctor chooses which antibiotic to use.\n* Receive all other usual hospital care for their COPD flare-up.\n* Have check-ups about 3-5 days, 7 days, 14 days and 30 days after joining the trial, in hospital or by telephone, to record their symptoms, any side effects and any return to hospital.\n\nAbout 560 adults will take part.",[119,120],"COPD","Acute Exacerbation of COPD",[119,122,123,85,124],"ACOPD","Antibiotic duration","ICU","NOT_YET_RECRUITING","2026-10-06",{"date":128,"type":129},"2026-10-07","ACTUAL",{"date":131,"type":113},"2026-10-26",{"date":133,"type":113},"2027-02-28",{"name":5,"class":6},1]