NCT07703644Not yet recruiting
Ceftazidime-Avibactam PK/PD and Resistance in Hematology Patients
Prospective Exploratory Study of Standard-Dose Ceftazidime-Avibactam PK/PD Target Attainment, Clinical Outcomes, and Induced Resistance in Patients With Hematological Malignancies
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 9 Jul 2026
- Primary completion date
- 9 Jul 2027
- Lead sponsor
- Sizhou Feng
- Diseases
- Childhood cancers
- NCT number
- NCT07703644
What you commit to
- Study type: Observational
- Planned participants: 60
- From 9 Jul 2026 to the primary completion date, 9 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Confirmed infection caused by metallo-beta-lactamase (MBL)-producing pathogens, without receiving appropriate combination therapy.
Other illness
- Known severe allergy or hypersensitivity to ceftazidime, avibactam, cephalosporins, or other beta-lactam antibiotics.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study inclusion.
Other
- Expected survival time of less than 72 hours.
- Inability to complete critical pharmacokinetic (TDM) or microbiological sampling.
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.