[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hospital-acquired-bacterial-pneumonia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hospital-acquired-bacterial-pneumonia":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100522816","phase-2-a-clinical-trial-to-assess-the-safety-and-pk-of-omn6-in-habp-or-vabp-caused-by-acinetobacter-baumannii-complex-100522816",false,"NCT06087536","A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex","A Prospective, Multinational, Multicenter, Randomized, Sequential, Double-blind, Placebo-controlled, Phase 2a Clinical Trial to Assess the Safety and Pharmacokinetics of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (ABC).","Inclusion Criteria:\n\n1. A signed informed consent form.\n2. Male or female patients 18 years or older\n3. A diagnosis of either a HABP or a VABP\n4. ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens\n5. Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization.\n6. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24\n\nExclusion Criteria:\n\n1. Moderate to severe reduction of renal function\n2. Liver dysfunction\n3. Evidence of septic shock\n4. Acute respiratory distress syndrome.\n5. Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).\n6. History of any known hypersensitivity to colistin or to carbapenems\n7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data","ALL","18 Years","99 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.",[27,28],"Hospital-acquired Bacterial Pneumonia","Ventilator-associated Bacterial Pneumonia",[30],"HABP VABP ABC Acinetobacter baumannii pneumonia","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2026-05-14",{"date":39,"type":21},"2027-03",{"name":41,"class":42},"Omnix Medical Ltd","INDUSTRY",6,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100593254","phase-4-optimising-treatment-for-severe-gram-negative-bacterial-infections-100593254","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",{"count":53,"type":21},600,[55],"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.",[58,59,60,61,62],"Bloodstream Infection","Ventilator Associated Bacterial Pneumonia","Hospital Acquired Bacterial Pneumonia","Carbapenem Resistant Bacterial Infection","Multidrug Resistance","2025-05-26",{"date":65,"type":35},"2025-06-04",{"date":67,"type":35},"2025-04-21",{"date":69,"type":21},"2028-12-31",{"name":71,"class":72},"National University of Singapore","OTHER",41]