Carbapenem Resistant Bacterial Infection / Severe Sepsis / Ceftazidime-avibactam · Observational Study

Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed prospective observational study registered to characterize plasma concentrations and pharmacokinetics of ceftazidime-avibactam in critically ill patients, including those on renal replacement therapy. The registry record does not contain posted results, efficacy data, or clinical outcomes; it describes study design and planned analyses only.

What was studied

Observational. Severe Sepsis, Carbapenem Resistant Bacterial Infection; age from 18 Years. Intervention: Ceftazidime-avibactam. n = 33. 1 site: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This PK characterization study may inform future dosing strategies for ceftazidime-avibactam in critical illness and renal dysfunction; however, no clinical efficacy, safety outcomes, or dosing recommendations are provided in this registry record.

Plain-language summary

This is a completed observational registry study of pharmacokinetic monitoring with no posted results; it characterizes drug concentrations and dosing but does not yet report efficacy or clinical outcomes.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Plasma drug concentrations of CAZ and AVI after first-dose administration (assessed at 0, 1, 2, 4, 6, and 8 hours after the first-dose infusion.); Plasma drug concentrations of CAZ and AVI at steady state (assessed at 0, 1, 2, 4, 6, and 8 hours after the steady-state infusion.); Population pharmacokinetic characterization and PK/PD-based dosing evaluation of CAZ-AVI (assessed at After completion of pharmacokinetic data collection)

DesignObservational

PopulationSevere Sepsis, Carbapenem Resistant Bacterial Infection; age from 18 Years

Sample size33

InterventionCeftazidime-avibactam

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment33

Study typeObservational

Primary outcome measure 1Plasma drug concentrations of CAZ and AVI after first-dose administration at 0, 1, 2, 4, 6, and 8 hours

Primary outcome measure 2Plasma drug concentrations of CAZ and AVI at steady state at 0, 1, 2, 4, 6, and 8 hours

Primary outcome measure 3Population pharmacokinetic characterization and PK/PD-based dosing evaluation of CAZ-AVI

Clinical bottom line

Caveats

Results are not posted in this registry record; clinical outcomes and efficacy are not reported.
Observational design without control group; no causal inferences about dosing benefit can be drawn.
Study location is a single centre (First Affiliated Hospital of Zhejiang University); generalizability to other populations unclear.
PK/PD target attainment analysis and dosing recommendations are described as planned but not yet reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective observational study with planned PK sampling; no control or randomization.

Directness

moderate

Measures plasma concentrations and PK/PD target attainment; clinical outcomes not stated.

Consistency

insufficient

Registry record does not report results or comparative data.

Risk of bias

insufficient

No results posted; observational design carries selection and confounding risk.

Sample adequacy

limited

33 participants enrolled; sample size adequate for PK but not powered for clinical outcomes.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05413343). This is a study registration, not published results. Lead sponsor: First Affiliated Hospital of Zhejiang University. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 33 participants (ACTUAL). Conditions: Severe Sepsis, Carbapenem Resistant Bacterial Infection. Interventions: DRUG: Ceftazidime-avibactam. Primary outcome measures: Plasma drug concentrations of CAZ and AVI after first-dose administration , 0, 1, 2, 4, 6, and 8 hours after the first-dose infusion.; Plasma drug concentrations of CAZ and AVI at steady state , 0, 1, 2, 4, 6, and 8 hours after the steady-state infusion.; Population pharmacokinetic characterization and PK/PD-based dosing evaluation of CAZ-AVI , After completion of pharmacokinetic data collection. Brief summary: This prospective observational study is conducted at the First Affiliated Hospital of Zhejiang University School of Medicine from June 1, 2021 to January 1, 2024. The study aims to characterize the population pharmacokinetics of ceftazidime (CAZ) and avibactam (AVI) in critically ill patients receiving ceftazidime-avibactam (CAZ-AVI), including patients with and without renal replacement therapy (RRT). Plasma concentrations of CAZ and AVI will be measured after the first-dose and steady-state administrations. Population pharmacokinetic and pharmacokinetic/pharmacodynamic target-attainment analyses will be performed to explore dosing strategies according to renal function and RRT status.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

First Affiliated Hospital of Zhejiang UniversityNCT05413343Carbapenem Resistant Bacterial InfectionSevere SepsisCeftazidime-avibactam