[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"klebsiella-pneumoniae-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:klebsiella-pneumoniae-infections":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":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100645752","ceftazidime-avibactam-pkpd-and-resistance-in-hematology-patients-100645752",false,"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.","ALL","16 Years",{"count":20,"type":21},60,"ESTIMATED","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.",[25,26,27,28,29],"Hematologic Neoplasms","Gram-Negative Bacterial Infections","Pseudomonas Aeruginosa Infection","Klebsiella Pneumoniae Infections","Drug Resistance, Bacterial",[31,32,33,34,35,36,37],"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":41,"type":42},"2026-07-14","ACTUAL",{"date":44,"type":21},"2026-07-09",{"date":46,"type":21},"2027-07-09",{"name":48,"class":49},"Sizhou Feng","OTHER"]