[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multidrug-resistance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multidrug-resistance":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100593254","phase-4-optimising-treatment-for-severe-gram-negative-bacterial-infections-100593254",false,"NCT07004049","Optimising TREATment for Severe Gram-Negative Bacterial Infections","TREAT-GNB [CR-GNB]","TREAT-GNB","Inclusion Criteria:\n\nA: Bloodstream infections\n\na) Suitable for at least 2 antibiotic regimens in the site randomisation list\n\n1. Growth of Gram-negative bacilli identified from blood culture(s)\n2. Receiving or planning to receive intravenous antibiotics\n3. Expected time from blood culture sampling to randomisation is ≤ 96 hours.\n\nOR\n\nB: Ventilator-associated pneumonia \u002F hospital-acquired pneumonia a) Suitable for at least 2 antibiotic regimens in the site randomisation list b) Infection syndrome definitions\\^( (US Centers for Disease Control and Prevention National Healthcare Safety Network)3: i) At least one of the following:\n\n1. temperature \\> 38 °C\n2. white blood cell count ≥ 12,000 cells\u002Fmm3 (12 x 109\u002FL, 12 x 103\u002FµL) or ≤ 4,000 cells\u002Fmm3 (4 x 109\u002FL, 4 x 103\u002FµL)\n3. altered mental status with no other causes in \\> 70 years old; AND ii) Two or more chest imaging tests demonstrating at least one of the following:\n\n1\\) new and progressive OR progressive and persistent infiltrate 2) new and persistent OR progressive and persistent consolidation 3) new and persistent OR progressive and persistent cavitation; AND iii) At least two of the following:\n\n1. new onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased in suctioning requirements\n2. new onset or worsening tachypnoea or dyspnoea\n3. rales or bronchial breath sounds\n4. worsening gas exchange defined by oxygen desaturations (e.g., PaO2\u002FFiO2 \\\u003C 240), increased oxygen requirements or increased ventilation demand.\n\n   c) Hospital admission \\> 48 hours d) Predominant growth of Gram-negative bacilli identified from respiratory tract specimen(s)\\*; e) Receiving or planning to receive intravenous antibiotics f) Expected time from respiratory culture sampling to randomisation is ≤ 96 hours\n\n   AND\n\n   C: CR-GNB antibiotic backbone domain\n\n   a) Gram-negative bacilli belonging to Acinetobacter baumannii-calcoaceticus complex, Pseudomonas aeruginosa or Enterobacterales b) Carbapenem resistance in isolate detected - i) Phenotypically via conventional microbiology testing: meropenem \u002F imipenem \u002F ertapenem resistance; OR ii) Genotypically via PCR or next generation sequencing: presence of genes associated with carbapenemase production (eg. blaNDM, blaKPC, blaIMP, blaIMI, blaVIM, blaOXA-48-like).\n\n   Exclusion Criteria:\n   1. Treating team deems enrolment in the study is not in the best interest of the patient\n   2. Patient is on end-of-life care\n   3. Patient is incarcerated in a correctional facility\n   4. Participation in any interventional study activities outlined in the TREAT-GNB study within the last 90 days\n   5. Pregnant women and children\n\n      OR\n   6. Polymicrobial bloodstream infection","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","TREAT-GNB is an innovative trial to expedite the evaluation of various antibiotic choices and treatment strategies for severe multidrug-resistant Gram-negative bacterial infections, specifically bloodstream and lower respiratory tract infections. This approach combines platform trial elements with adaptive clinical designs to streamline the evaluation of various treatment options and optimise resource utilisation. The overall aim of the TREAT-GNB platform trial is to identify interventions that improve survival in patients with severe infections due to Gram-negative bacteria.\n\nIn the CR-GNB silo of TREAT-GNB, the primary objective is to quantify the effect on all-cause mortality at 28 days of a range of interventions in patients with bloodstream infections, ventilator-associated pneumonia, and hospital-acquired pneumonia caused by CR-GNB.",[27,28,29,30,31],"Bloodstream Infection","Ventilator Associated Bacterial Pneumonia","Hospital Acquired Bacterial Pneumonia","Carbapenem Resistant Bacterial Infection","Multidrug Resistance","RECRUITING","2025-05-26",{"date":35,"type":36},"2025-06-04","ACTUAL",{"date":38,"type":36},"2025-04-21",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"National University of Singapore","OTHER",41,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100564881","international-surveillance-of-antimicrobial-resistance-in-cirrhosis-related-infections-100564881","NCT06634940","International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections","Inclusion Criteria:\n\n* Episodes of culture-confirmed bacterial infections\n* Patients diagnosed with cirrhosis\n* Infections diagnosed either at the time of hospital admission or during hospitalization\n\nExclusion Criteria:\n\n* History of solid organ or hematopoietic stem cell transplantation\n* Declined to participate in the study","17 Years",{"count":53,"type":21},1000,"1 Week","OBSERVATIONAL","What is this study about?\n\nThis study tracks antibiotic resistance in patients with cirrhosis who develop bacterial infections. Cirrhosis is a condition where the liver is severely scarred, and people with cirrhosis are at high risk for serious bacterial infections.\n\nWhy is this study important?\n\nBacterial infections are common in patients with cirrhosis, affecting 25-46% of those who are hospitalized. These infections can be life-threatening, with 1 in 4 patients dying from complications. Many of these infections are becoming harder to treat because the bacteria are resistant to antibiotics. Infections caused by resistant bacteria are increasing, which makes finding the right antibiotic quickly even more difficult.\n\nIn other regions of the world, guidelines exist to help doctors choose the right antibiotics for cirrhosis patients. However, in Latin America, we don't have specific guidelines for our region, and doctors currently rely on recommendations from the U.S. or Europe. These guidelines may not reflect the local patterns of bacterial infections and resistance we see here.\n\nWhat is the goal of this study?\n\nThe main goal of this study is to create a long-term system to track how bacteria respond to antibiotics in patients with cirrhosis in Latin America. By collecting data from hospitals across different countries, we aim to:\n\n* Identify how many infections are caused by multidrug-resistant bacteria.\n* Understand how antibiotics (such as ceftriaxone, vancomycin, and carbapenems) act against these infections.\n* Generate reports informing bacterial resistance patterns to help doctors make better patient treatment decisions.\n\nWhat do we hope to achieve?\n\nWe hope the data we collect will help develop guidelines for patients with cirrhosis in Latin America. These guidelines will ensure that doctors use the most effective antibiotics based on real-time data from our region. This should improve patient outcomes and help prevent the spread of resistant bacteria.",[58,59,31],"Cirrhosis","Bacterial Infections",[61,62,63,64,65,66,67,68],"antibiotics","empirical treatment","methicillin-resistant Staphylococcus aureus","extended-spectrum beta-lactamase-producing organisms","Carbapenemase-Producing Enterobacteriaceae","de-escalation","guidelines","empiric antibiotics","2024-10-08",{"date":71,"type":36},"2024-10-10",{"date":73,"type":36},"2020-11-15",{"date":75,"type":21},"2031-06-01",{"name":77,"class":43},"Hospital Italiano de Buenos Aires",1]