[{"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,4,0,[8,44,81,113],{"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 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 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","RECRUITING","2026-07-27",{"date":34,"type":35},"2026-07-28","ACTUAL",{"date":37,"type":35},"2026-07-25",{"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":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":43},"100645752","ceftazidime-avibactam-pkpd-and-resistance-in-hematology-patients-100645752","NCT07703644","Ceftazidime-Avibactam PK\u002FPD and Resistance in Hematology Patients","Prospective Exploratory Study of Standard-Dose Ceftazidime-Avibactam PK\u002FPD Target Attainment, Clinical Outcomes, and Induced Resistance in Patients With Hematological Malignancies","CZA-TDM","Inclusion Criteria:\n\n* Age 16 years or older.\n* Diagnosed with hematological malignancies (including but not limited to acute leukemia, lymphoma, multiple myeloma, or myelodysplastic syndrome \\[MDS\\]) or having received\u002Fundergoing autologous or allogeneic hematopoietic stem cell transplantation (HSCT).\n* Prescribed ceftazidime-avibactam (CAZ-AVI) therapy for suspected or confirmed Gram-negative bacterial infections based solely on routine clinical decisions.\n* Expected duration of CAZ-AVI therapy is no less than 72 hours.\n* Willing and able to comply with the study-specified therapeutic drug monitoring (TDM) and microbiological surveillance.\n\nExclusion Criteria:\n\n* Known severe allergy or hypersensitivity to ceftazidime, avibactam, cephalosporins, or other beta-lactam antibiotics.\n* Confirmed infection caused by metallo-beta-lactamase (MBL)-producing pathogens, without receiving appropriate combination therapy.\n* Expected survival time of less than 72 hours.\n* Inability to complete critical pharmacokinetic (TDM) or microbiological sampling.\n* Pregnancy or lactation.\n* Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study inclusion.","16 Years",{"count":54,"type":21},60,"OBSERVATIONAL","This is a prospective, single-arm, observational, exploratory clinical study to evaluate whether the standard fixed dose of ceftazidime-avibactam (CAZ-AVI) achieves sufficient drug exposure (pharmacokinetic\u002Fpharmacodynamic, or PK\u002FPD targets) in patients with blood cancers (or those undergoing stem cell transplantation).\n\nPatients with hematological malignancies are at high risk for severe, drug-resistant Gram-negative bacterial infections due to weakened immune systems. CAZ-AVI is a critical antibiotic used to treat these infections. However, there is limited evidence on whether the standard recommended dose achieves adequate drug concentrations for both ceftazidime and avibactam simultaneously in this specific patient group, and whether low drug exposure drives the development of antibiotic resistance during treatment.\n\nThis study will enroll 60 participants who are already prescribed CAZ-AVI by their treating physicians based on routine clinical needs. The study will not change or interfere with any clinical treatment decisions. To measure drug levels, 5 small blood samples (about 2-3 mL each) will be collected within one dosing interval after the drug reaches a steady level in the body (typically 48 to 72 hours after starting treatment). Microbiological samples (such as blood cultures or swabs) will also be collected at multiple time points to monitor bacterial clearance and detect any newly developed resistance. Participants will be followed up for clinical outcomes and survival status up to 30 days after the completion of treatment.\n\nThe primary goal of this study is to determine the percentage of patients who achieve the target drug exposure for both ceftazidime and avibactam simultaneously. The secondary goals are to observe clinical cure rates, bacterial clearance rates, 30-day survival, and the rate of newly induced antibiotic resistance during therapy.",[58,59,28,60,61],"Hematologic Neoplasms","Gram-Negative Bacterial Infections","Klebsiella Pneumoniae Infections","Drug Resistance, Bacterial",[63,64,65,66,67,68,69],"Ceftazidime-avibactam","CAZ-AVI","Therapeutic Drug Monitoring","TDM","PK\u002FPD Target Attainment","Hematopoietic Stem Cell Transplantation","Induced Resistance","NOT_YET_RECRUITING","2026-07-08",{"date":73,"type":35},"2026-07-14",{"date":75,"type":21},"2026-07-09",{"date":77,"type":21},"2027-07-09",{"name":79,"class":80},"Sizhou Feng","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"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":90,"type":21},128,[92],"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.",[95,96,97,28],"Infection in ICU","Sepsis","Septic Shock",[99,100,101,102],"ceftazidime","intensive care unit","pharmacokinetics","individualised dosing regimen","2025-11-21",{"date":105,"type":35},"2025-11-24",{"date":107,"type":21},"2026-01",{"date":109,"type":21},"2026-11",{"name":111,"class":80},"Centre Hospitalier Universitaire de Saint Etienne",8,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":119,"enrollmentInfo":120,"targetDuration":122,"studyType":55,"phases":4,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"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":121,"type":21},100,"28 Days","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.",[125,28],"Rapid Detection","2025-08-13",{"date":128,"type":35},"2025-08-14",{"date":130,"type":21},"2025-09-01",{"date":132,"type":21},"2025-11-30",{"name":134,"class":80},"The First Affiliated Hospital with Nanjing Medical University"]