Ceftazidime-Avibactam PK/PD and Resistance in Hematology Patients

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Conditions studied: Hematologic Neoplasms, Gram-Negative Bacterial Infections, Pseudomonas Aeruginosa Infection, Klebsiella Pneumoniae Infections, Drug Resistance, Bacterial

In brief

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.

Key facts

Study ID: NCT07703644
Run by: Sizhou Feng
People needed: 60
Starts: 2026-07-09
Expected to finish: 2027-07-09
Last updated by the study team: 2026-07-14

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 16 years or older.
Diagnosed with hematological malignancies (including but not limited to acute leukemia, lymphoma, multiple myeloma, or myelodysplastic syndrome [MDS]) or having received/undergoing autologous or allogeneic hematopoietic stem cell transplantation (HSCT).
Prescribed ceftazidime-avibactam (CAZ-AVI) therapy for suspected or confirmed Gram-negative bacterial infections based solely on routine clinical decisions.
Expected duration of CAZ-AVI therapy is no less than 72 hours.
Willing and able to comply with the study-specified therapeutic drug monitoring (TDM) and microbiological surveillance.

You may not qualify if…

Known severe allergy or hypersensitivity to ceftazidime, avibactam, cephalosporins, or other beta-lactam antibiotics.
Confirmed infection caused by metallo-beta-lactamase (MBL)-producing pathogens, without receiving appropriate combination therapy.
Expected survival time of less than 72 hours.
Inability to complete critical pharmacokinetic (TDM) or microbiological sampling.
Pregnancy or lactation.
Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study inclusion.

Where it is running

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

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