[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nosocomial-respiratory-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nosocomial-respiratory-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100655996","resistance-optimised-antimicrobial-dosing-in-critically-ill-patients-a-randomised-controlled-trial-100655996",false,"NCT07820501","Resistance-Optimised Antimicrobial Dosing in Critically Ill Patients, a Randomised Controlled Trial","ROAD-RCT","Inclusion Criteria:\n\n1. The patient is ≥ 18 years of age.\n2. The patient has been admitted to the hospital for ≥ 48 h or was discharged from a hospital within the preceding seven days and is currently admitted to the ICU.\n3. The patient is intubated and mechanically ventilated.\n4. The patient is diagnosed with a probable or definitive respiratory infection and exhibits at least one of the following clinical features:\n\n   I. New onset or worsening pulmonary symptoms or signs: increase in volume and\u002For purulence of respiratory secretions, worsening of hypoxaemia requiring an increase in the FiO2 and\u002For need for acute changes in the ventilator support system to support oxygenation.\n\n   II. Radiological findings deemed consistent with a respiratory infection. III. Clinical signs and symptoms of infection: fever \\> 38 °C, leucocytosis, increase in acute phase reactants such as C-reactive protein or procalcitonin.\n5. The patient has been commenced on empiric or targeted treatment with piperacillin\u002Ftazobactam or meropenem for the management of a respiratory infection, with an expected duration of treatment of \\> 72 h.\n6. Piperacillin\u002Ftazobactam or meropenem have been commenced in an ICU that participates in ROAD-RCT.\n7. The patient has an appropriate arterial or venous access for blood sampling.\n\nExclusion Criteria:\n\n1. The patient is known or suspected to be pregnant.\n2. The patient has a known allergy to piperacillin\u002Ftazobactam or meropenem.\n3. The patient has a community-acquired respiratory infection or chemical pneumonitis in the context of bronchoaspiration.\n4. The patient has received piperacillin\u002Ftazobactam or meropenem for more than 48 h.\n5. The antimicrobial dose initiated empirically is \\> 4 g daily for meropenem and \\> 18 g daily (16 g piperacillin \u002F 2 g tazobactam) for piperacillin\u002Ftazobactam (excluding the loading dose) in patients who are not receiving renal replacement therapy.\n6. The antimicrobial dose initiated empirically is \\> 18 g daily (16 g piperacillin \u002F 2 g tazobactam) for piperacillin\u002Ftazobactam and \\> 2 g daily for meropenem in patients receiving renal replacement therapy (Table 1).\n7. The patient's death is deemed imminent and inevitable.\n8. The patient has previously been enrolled in ROAD-RCT.\n9. The patient is or has been enrolled in another antimicrobial clinical trial that may interfere with the intervention as determined by the study investigators.\n10. The patient has a baseline (at ICU admission or enrolment) positive rectal and\u002For nasopharyngeal screening swab, or is known to have been colonised within the past 6 months, with any of the following beta-lactam-resistant Gram-negative microorganism(s): carbapenem-resistant Enterobacterales, P. aeruginosa with DTR or carbapenem-resistant A. baumannii complex.\n11. There is a prior known or likely reason that the patient would not consent if they were able to be asked.","ALL","18 Years",{"count":19,"type":20},610,"ESTIMATED","INTERVENTIONAL",[23],"NA","Critically ill people who need a breathing machine often develop hospital-acquired lung infections. These infections are commonly treated with the antibiotics piperacillin\u002Ftazobactam or meropenem. However, standard antibiotic doses may not always provide the right drug levels to fully treat the infection or help prevent antibiotic resistance.\n\nThe purpose of this study is to determine whether a resistance-optimized antibiotic dosing approach improves recovery compared with standard antibiotic dosing in critically ill adults with hospital-acquired respiratory infections.\n\nParticipants will be randomly assigned to 1 of 2 groups:\n\nResistance-optimized precision dosing - guided by therapeutic drug monitoring and dosing software.\n\nStandard care - antibiotic dosing used at the participating hospital.\n\nAll participants will receive treatment with either piperacillin\u002Ftazobactam or meropenem as determined by their treating clinical team. The study will compare whether the precision dosing approach leads to better clinical recovery, reduces the development of antibiotic-resistant bacteria, and is safe for participants.\n\nApproximately 610 mechanically ventilated adults will be enrolled from intensive care units in multiple countries. Participants will be followed for up to 28 days after starting study antibiotic treatment.",[26,27,28,29],"Hospital-acquired Pneumonia (HAP)","Ventilator-Associated Pneumonia (VAP)","Nosocomial Respiratory Infection","Critical Illness",[31,32,28,33,34,35,36,37,38,39],"Hospital-Acquired Pneumonia","Ventilator-Associated Pneumonia","Intensive Care Unit","Mechanical Ventilation","Antimicrobial Resistance","Therapeutic Drug Monitoring","Drug Dose Optimization","Randomized Controlled Trial","Precision Dosing","NOT_YET_RECRUITING","2026-09-09",{"date":43,"type":44},"2026-09-15","ACTUAL",{"date":46,"type":20},"2026-11",{"date":48,"type":20},"2029-09",{"name":50,"class":51},"The University of Queensland","OTHER"]