[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pseudomonas-aeruginosa-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pseudomonas-aeruginosa-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,77],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630830","phase-1-mp101-in-adults-with-acute-pseudomonas-aeruginosa-pneumonia-100630830",false,"NCT07492771","MP101 in Adults With Acute Pseudomonas Aeruginosa Pneumonia","A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of MP101 in Adult Patients With Acute Pseudomonas Aeruginosa Pneumonia","MP101-1001","Inclusion Criteria:\n\n* Subjects aged 19 years or older.\n* Clinical diagnosis of acute pneumonia with radiologic evidence of pulmonary infiltrates.\n* Confirmed Pseudomonas aeruginosa (PA) infection via valid respiratory specimens.\n* PA isolate demonstrates susceptibility to MP101 and non-susceptibility to current antibiotic therapy.\n* Adequate organ function as defined by hematological, hepatic, and renal laboratory parameters .\n\nExclusion Criteria:\n\n* Persistent septic shock or hemodynamically unstable condition.\n* Active pulmonary tuberculosis or suspected non-bacterial pneumonia.\n* Significant pleural effusion or lung abscess requiring therapeutic drainage.\n* Clinically significant cardiovascular, hepatic, or renal impairment .\n* Immunocompromised status or history of hematological malignancies.\n* Known hypersensitivity to bacteriophages, study components, or concomitant antibiotics.\n* Participation in another clinical trial within 30 days prior to screening.\n* Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study.","ALL","19 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MP101 administered in addition to standard antibiotic therapy in adult patients with acute Pseudomonas aeruginosa pneumonia. The study will also assess the pharmacokinetic and pharmacodynamic characteristics of MP101 and its antibacterial activity, including changes in P. aeruginosa burden in sputum and changes in susceptibility to MP101 and concomitant antibiotics.",[27,28],"Pneumonia - Bacterial","Pseudomonas Aeruginosa Infection",[30],"Acute Pseudomonas Aeruginosa Pneumonia","NOT_YET_RECRUITING","2026-05-22",{"date":34,"type":35},"2026-05-26","ACTUAL",{"date":37,"type":21},"2026-06-15",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"MicrobiotiX Co., Ltd","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100599525","early-optimization-of-ceftazidime-regimen-in-critical-care-100599525","NCT07085624","Early Optimization of Ceftazidime Regimen in Critical Care","FORTOPTIM_1","Inclusionn criteria:\n\n* Patient hospitalized in intensive care unit for an expected duration of at least 72 hours, with an infection for which initiation of ceftazidime therapy is being considered.\n* Patient with an arterial catheter for blood sampling.\n* Patients affiliated to or entitled under a social security scheme.\n\nExclusion Criteria:\n\n* Pregnant woman, parturient, nursing mother;\n* Person deprived of liberty, hospitalized without consent,\n* Adults under legal protection (guardianship-curatorship)\n* Patients undergoing extra-renal purification or whose CKD-EPI at the start of treatment is less than 15 ml\u002Fmin.","18 Years",{"count":53,"type":21},128,[55],"NA","Hospital-acquired infections, most of which are caused by Gram-negative bacteria, are common in intensive care units and have a major impact on patient prognosis. Patient survival in severe sepsis and septic shock depends on the early administration of appropriate antibiotic therapy, with mortality increasing by 7.6% for each hour of delay, justifying the probabilistic use of broad-spectrum antibiotics such as ceftazidime, an essential betalactamine, particularly used for its activity against Pseudomonas aeruginosa, a frequent pathogen in nosocomial infections.\n\nIt is currently recommended that ceftazidime should initially be administered as a 2g loading dose, followed by maintenance treatment by continuous infusion, at a dose adapted to renal function.\n\nThe recommended dosage regimen, with its 2g loading dose, was developed using the median value of parameters from a pharmacokinetic model. This explains the findings of many critical care studies, which have found that 40-60% of patients initially have concentrations below target with the recommended dosing regimen.\n\nIn the context of critical care, maintaining concentrations within the target therapeutic range is difficult due to variations in the elimination clearance of ceftazidime. Ceftazidime is mainly eliminated by the kidneys. Critical patients may have increased glomerular filtration rate, or, conversely, impaired renal function, with rapid variations in the event of severe infection. This leads to high intra- and inter-individual variability, and increases the risk of antibiotic under- or overdose when the maintenance dose is administered at a fixed dose (6g\u002Fd continuously). This high variability can also be observed in the volume of distribution (capillary leakage, oedema, perfusion volumes, effusions ...).\n\nIn order to propose an individualised dosing regimen, we therefore propose an iterative randomised study to :\n\n* Step 1: FORTOPTIM\\_1 Evaluation of an optimised dosage regimen based on literature data compared with the standard psological regimen.\n* Step 2: FORTOPTIM\\_2 Build a pharmacokinetic model from the prospective data obtained in step 1. Based on this model, an individualised dosage regimen (loading dose and maintenance dose) will be obtained for step 3.\n* Step 3: FORTOPTIM\\_3 Prospectively evaluate in a randomised trial the individualised dosing regimen previously defined (Step 2) by comparing it to the best dosing regimen determined in Step 1 or to the standard dosing regimen if there is no significant difference in Step 1.",[58,59,60,28],"Infection in ICU","Sepsis","Septic Shock",[62,63,64,65],"ceftazidime","intensive care unit","pharmacokinetics","individualised dosing regimen","2025-11-21",{"date":68,"type":35},"2025-11-24",{"date":70,"type":21},"2026-01",{"date":72,"type":21},"2026-11",{"name":74,"class":75},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",8,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":83,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":43},"100591906","rapid-detection-of-pseudomonas-aeruginosa-in-bronchoalveolar-lavage-fluid-using-label-free-single-particle-imaging-technology-and-assessment-of-post-treatment-efficacy-in-patients-with-pseudomonas-aeruginosa-infection-100591906","NCT06986512","Rapid Detection of Pseudomonas Aeruginosa in Bronchoalveolar Lavage Fluid Using Label-free Single-particle Imaging Technology and Assessment of Post-treatment Efficacy in Patients With Pseudomonas Aeruginosa Infection","Inclusion Criteria:\n\n* Aged 18 years and above\n* After admission, Pseudomonas aeruginosa was cultured in bronchoalveolar lavage fluid or lower respiratory tract aspirates\n\nExclusion Criteria:\n\n* Age under 18 years old or over 90 years old\n* Pregnancy, lactation period -","90 Years",{"count":85,"type":21},100,"28 Days","OBSERVATIONAL","The aim of this study is to observe specimens of bronchoalveolar lavage fluid from patients using a reflection enhanced dark-field scattering microscopy. By observing parameters such as the size, morphology, scattering intensity, and movement speed of pathogens, combined with the clinical characteristics of patients, a rapid diagnosis of Pseudomonas aeruginosa infection can be made. At the same time, the bronchoalveolar lavage fluid samples of patients infected with Pseudomonas aeruginosa before and after treatment were compared, and the quantity and vitality of Pseudomonas aeruginosa were observed to judge the efficacy of antibiotics.",[90,28],"Rapid Detection","2025-08-13",{"date":93,"type":35},"2025-08-14",{"date":95,"type":21},"2025-09-01",{"date":97,"type":21},"2025-11-30",{"name":99,"class":75},"The First Affiliated Hospital with Nanjing Medical University"]