[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645752":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":80,"overallStatus":87,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAZ-AVI Single-Arm Observation Group",null,"Patients with hematological malignancies or those undergoing hematopoietic stem cell transplantation (HSCT) who are prescribed standard-dose ceftazidime-avibactam (CAZ-AVI) for suspected or confirmed Gram-negative bacterial infections based solely on routine clinical decisions \\[4, 6.1, 17\\]. This group will undergo standard-of-care antibiotic therapy combined with protocol-specified therapeutic drug monitoring (TDM) and microbiological surveillance.",[13,14],"Drug: Ceftazidime-avibactam","Procedure: Therapeutic Drug Monitoring (TDM) and Microbiological Surveillance",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Ceftazidime-avibactam","Patients receive standard-dose ceftazidime-avibactam (CAZ-AVI) intravenously. The standard recommended dosage for adults is 2.5 g (ceftazidime 2.0 g and avibactam 0.5 g) administered every 8 hours via a 2-hour intravenous infusion, with adjustments made for renal impairment according to the drug's official product label. This study is purely observational; the initiation, dosing regimen, combination with other antibiotics, and duration of therapy are determined entirely by the treating physicians based on clinical routine, without any study-active interference.",[9],[22],"CAZ-AVI, Zavicefta, 思福妥",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"PROCEDURE","Therapeutic Drug Monitoring (TDM) and Microbiological Surveillance","Auxiliary non-interventional procedures added to routine care: 1) Standardized TDM sampling: 5 blood samples (2-3 mL each, total \\~15 mL) collected within a single dosing interval at steady state (48-72 hours after treatment initiation, typically after the 4th or 5th dose) to measure ceftazidime and avibactam plasma concentrations via LC-MS\u002FMS. 2) Microbiological surveillance: longitudinal collection of blood cultures, clinical infection site specimens, and oropharyngeal\u002Fperianal colonization swabs at Baseline, Day 3±1, Day 7±1, end of therapy, and 7 days post-therapy to monitor bacterial clearance and screen for newly induced resistance.",[9],[29],{"name":30,"affiliation":31,"role":32},"Sizhou Feng, MD","Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Xiaomeng Feng, MD, PhD","CONTACT","+86-22-23608592","fengxiaomeng@ihcams.ac.cn",[40],{"facility":41,"status":10,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences","Tianjin","Tianjin Municipality","300020","China","CN",{"type":48,"coordinates":49},"Point",[50,51],117.17667,39.14222,{"lat":51,"lon":50},[54],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Sizhou Feng","Director, Chief Physician, Professor","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":70,"type":71},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.",[75,76,77,78,79],"Hematologic Neoplasms","Gram-Negative Bacterial Infections","Pseudomonas Aeruginosa Infection","Klebsiella Pneumoniae Infections","Drug Resistance, Bacterial",[18,81,82,83,84,85,86],"CAZ-AVI","Therapeutic Drug Monitoring","TDM","PK\u002FPD Target Attainment","Hematopoietic Stem Cell Transplantation","Induced Resistance","NOT_YET_RECRUITING","2026-07-08",{"date":90,"type":91},"2026-07-14","ACTUAL",{"date":93,"type":71},"2026-07-09",{"date":95,"type":71},"2027-07-09",{"name":57,"class":6},1]