[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578997":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":45,"responsibleParty":61,"collaborators":27,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":27,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":27,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":27,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Meropenem","ACTIVE_COMPARATOR","Meropenem 2gm TDS over 3 hours infusion Teicoplanin 400 mg iv BD for 3 doses f\u002Fb 400 mg iv OD",[13,14],"Drug: Meropenem Injection","Drug: Teicoplanin",{"label":16,"type":17,"description":18,"interventionNames":19},"Ceftazidime avibactam","EXPERIMENTAL","Ceftazidime avibactam 2.5 gm iv TDS. Teicoplanin 400 mg iv BD for 3 doses f\u002Fb 400 mg iv OD",[20,14],"Drug: Ceftazidime-avibactam",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Meropenem Injection","Meropenem 2 gm iv TDS",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Ceftazidime-avibactam","Ceftazidime-avibactam 2.5 gm iv TDS",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Teicoplanin","Teicoplanin 400 mg iv BD 3 doses followed by 400mg iv OD",[16,9],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Dr Amanjot Kaur, MD","CONTACT","01146300000","amanjotbahri@gmail.com",{"name":43,"role":39,"phone":40,"phoneExt":27,"email":44},"Prof. Rakhi Maiwall, DM","rakhi_2011@yahoo.co.in",[46],{"facility":47,"status":27,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Institute of Liver & Biliary Sciences (ILBS)","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":54,"coordinates":55},"Point",[56,57],77.2148,28.62137,{"lat":57,"lon":56},[60],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"type":62,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100578997","comparison-of-efficacy-and-safety-of-ceftazidime-avibactam-versus-extended-infusions-of-high-dose-meropenem-in-patients-of-aclf-with-nosocomial-infections-100578997",false,"NCT06818565","Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. ACLF as per APASL criteria\n3. ACLF patients with nosocomial infections caused by carbapenem resistant organism (defined as suspected or documented evidence of infection after 48 hours of hospitalization) requiring antibiotics.\n\nExclusion Criteria:\n\n1. Severe septic shock with MOF requiring escalation of antibiotics\n2. Patients having known allergies to meropenem or Ceftazidime Avibactam\n3. Culture sensitivity showing isolate non susceptible to study drug being investigated.\n4. Already on either regimen, receiving meropenem or Ceftazidime Avibactam \\>48 hours.\n5. On mechanical ventilator support PF ratio \\\u003C 300.\n6. Patients on immunosuppression medication\n7. HCC or other malignancies\n8. CKD\n9. CAD\n10. Pregnancy or Lactation\n11. Post Liver Transplantation\n12. Refusal to consent\n13. PLWHA","ALL","18 Years",{"count":72,"type":73},150,"ESTIMATED","INTERVENTIONAL",[76],"NA","Acute on chronic liver failure patients are at high risk for nosocomial infections due to liver dysfunction, which impairs immune responses and increases vulnerability to infections. Key factors contributing to nosocomial infections in ACLF patients include ascites, use of invasive devices, and recent hospitalization, frequent need for broad spectrum antibiotics. Multidrug resistance is a growing issue, making treatment more challenging, common pathogens involved are gram negative bacteria such as Escherichia Coli and Klebsiella pneumoniae. Surveillance data show increasing carbapenem resistant enterobacterales (CRE) infection rates in cirrhotics, with high morbidity and mortality rates. The impact of these nosocomial infections is profound, significantly worsen outcomes in ACLF patients, leading to prolonged hospitalizations, increased health care costs and higher mortality rates. Early detection and effective antibiotic stewardship are essential to manage antibiotic resistance and improve patient outcomes. In this study we aim to compare efficacy and safety of Ceftazidime avibactam versus extended infusions of high dose Meropenem in patients of ACLF with nosocomial infections.",[79],"Acute-On-Chronic Liver Failure","NOT_YET_RECRUITING","2025-02-07",{"date":83,"type":84},"2025-02-10","ACTUAL",{"date":83,"type":73},{"date":87,"type":73},"2026-12-31",{"name":5,"class":6},1]