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Ceftazidime-Avibactam PK/PD and Resistance in Hematology Patients
Sponsor: Sizhou Feng
Summary
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/pharmacodynamic, or PK/PD targets) in patients with blood cancers (or those undergoing stem cell transplantation). Patients 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. This 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. The 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.
Official title: Prospective Exploratory Study of Standard-Dose Ceftazidime-Avibactam PK/PD Target Attainment, Clinical Outcomes, and Induced Resistance in Patients With Hematological Malignancies
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-07-09
Completion Date
2027-07-09
Last Updated
2026-07-14
Healthy Volunteers
No
Conditions
Interventions
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.
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/MS. 2) Microbiological surveillance: longitudinal collection of blood cultures, clinical infection site specimens, and oropharyngeal/perianal 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.
Locations (1)
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China