Severe SepsisNCT05413343

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

An observational study of Severe Sepsis and Carbapenem Resistant Bacterial Infection, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Sepsis, Carbapenem Resistant Bacterial Infection
What is being tested?: Ceftazidime-avibactam
Type of treatment: Injection or infusion
How many people: 33 participants
Where: 1 siteChina
Study dates: 1 Jun 2021to 20 Dec 2023
How long will I take part?: 30 Days
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population will comprise critically ill adult patients receiving ceftazidime-avibactam (CAZ-AVI) for carbapenem-resistant organism (CRO) infections at the intensive care unit of the First Affiliated Hospital, Zhejiang University School of Medicine.

Who may be able to join

Critically ill patients with severe sepsis(CRO infections) and treated with CAZ-AVI(culture-confirmed CRO susceptible to CAZ-AVI);
Age ≥ 18 years;
Expected ICU stay ≥48 hours.
Hemoglobin >70 g/L during the pharmacokinetic blood-sampling period；
The patient or authorized persons agree and sign the informed consent.

Who cannot join

Expected ICU stay <48 hours.
Pregnant woman.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital,College of Medicine,Zhejiang University
Hangzhou, Zhejiang, 310000

Other trials in China

About this study

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.

Read the detailed description

This is a prospective, single-center observational cohort study of critically ill adult patients receiving CAZ-AVI for carbapenem-resistant organism (CRO) infections. Arterial blood samples (3 mL) will be collected at 0, 1, 2, 4, 6, and 8 hours after the first-dose and steady-state CAZ-AVI infusions. Blood samples will be centrifuged at 4°C and 4000 rpm for 10 min, and the separated plasma will be stored at -80°C until measurement of ceftazidime (CAZ) and avibactam (AVI) concentrations. Plasma concentrations of CAZ and AVI will be quantified using ultrahigh-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UHPLC-Q-TOF). Clinical and laboratory characteristics will be recorded, together with RRT-related treatment parameters in patients receiving RRT. Population pharmacokinetic(PPK) models of CAZ and AVI will be developed using the collected concentration and clinical data.The resulting PPK models will subsequently be used in Monte Carlo simulations (MCSs) to identify candidate model-informed dosing regimens across renal-function and RRT strata.

Conditions: Severe Sepsis, Carbapenem Resistant Bacterial Infection
Being tested: Ceftazidime-avibactam
Keywords: Severe sepsis, Ceftazidime-avibactam, Population pharmacokinetics (PPK), Pharmacokinetic (PK), Critically ill Patients, Pharmacodynamic (PD), Renal replacement therapy
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ceftazidime-avibactamDrug
Critically ill adult patients (≥18 years) receiving intravenous CAZ-AVI for carbapenem-resistant organism (CRO) infections will be enrolled. Arterial blood samples (3 mL) will be collected at 0, 1, 2, 4, 6, and 8 hours after the first-dose and steady-state CAZ-AVI infusions for measurement of plasma CAZ and AVI concentrations.

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma drug concentrations of CAZ and AVI after first-dose administration
Plasma concentrations of CAZ and AVI will be measured after the first-dose infusion.
Measured: 0, 1, 2, 4, 6, and 8 hours after the first-dose infusion.
Plasma drug concentrations of CAZ and AVI at steady state
Plasma drug concentrations of CAZ and AVI will be measured after the steady-state infusion
Measured: 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
Population pharmacokinetic models of ceftazidime and avibactam will be developed using plasma concentration and clinical data from critically ill patients. Pharmacokinetic/pharmacodynamic analyses will be performed to evaluate dosing regimens across different levels of renal function, including patients receiving renal replacement therapy (RRT).
Measured: After completion of pharmacokinetic data collection

Secondary outcomes (6)

Microbiological clearance
Microbiological clearance assessed based on follow-up microbiological culture results.
Measured: 14 day after the onset of infection
Infection-related mortality
Infection-related mortality within 14 days after the onset of infection.
Measured: 14 day after the onset of infection
Treatment outcome
Treatment outcome within 14 days after the onset of infection.
Measured: 14 day after the onset of infection
all-cause mortality
30 day all-cause mortality
Measured: 30 day after the onset of infection
length of stay
Post-infection ICU length of stay
Measured: Day 1 is defined as the day of confirmed diagnosis, the duration from confirmed diagnosis to ICU discharge will be measured.
length of stay
Total ICU length of stay.
Measured: From ICU admission to ICU discharge will be measured(assessed up to 120 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202120 Dec 2023

First posted10 Jun 2022
Study start1 Jun 2021
Primary completion8 Sep 2023
Study completion20 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe SepsisStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 33 participants (actual)
Target duration: 30 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT05413343
Sponsor's protocol ID: 2022-468
Status last verified: Jul 2026
First submitted: 7 Jun 2022
Last updated: 10 Sep 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Respect ethics and protect patient privacy

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue

All Severe Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients
ClinicalTrials.gov ID: NCT05413343
Acronym / sponsor ID: 2022-468
Conditions: Severe Sepsis, Carbapenem Resistant Bacterial Infection
Keywords: Severe sepsis, Ceftazidime-avibactam, Population pharmacokinetics (PPK), Pharmacokinetic (PK), Critically ill Patients, Pharmacodynamic (PD), Renal replacement therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
Study start: 1 Jun 2021 (actual)
Primary completion: 8 Sep 2023 (actual)
Study completion: 20 Dec 2023 (actual)
First posted: 10 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 30 Days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will comprise critically ill adult patients receiving ceftazidime-avibactam (CAZ-AVI) for carbapenem-resistant organism (CRO) infections at the intensive care unit of the First Affiliated Hospital, Zhejiang University School of Medicine.

Key inclusion criteria (5 listed)

Critically ill patients with severe sepsis(CRO infections) and treated with CAZ-AVI(culture-confirmed CRO susceptible to CAZ-AVI);
Age ≥ 18 years;
Expected ICU stay ≥48 hours.
Hemoglobin >70 g/L during the pharmacokinetic blood-sampling period；
The patient or authorized persons agree and sign the informed consent.

Key exclusion criteria (2 listed)

Expected ICU stay <48 hours.
Pregnant woman.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ceftazidime-avibactamCritically ill adult patients (≥18 years) receiving intravenous CAZ-AVI for carbapenem-resistant organism (CRO) infections will be enrolled. Arterial blood samples (3 mL) will be collected at 0, 1, 2, 4, 6, and 8 hours after the first-dose and steady-state CAZ-AVI infusions for measurement of plasma CAZ and AVI concentrations.	Drug	–

Primary outcome

Plasma drug concentrations of CAZ and AVI after first-dose administration
Time frame: 0, 1, 2, 4, 6, and 8 hours after the first-dose infusion.
Plasma concentrations of CAZ and AVI will be measured after the first-dose infusion.
Plasma drug concentrations of CAZ and AVI at steady state
Time frame: 0, 1, 2, 4, 6, and 8 hours after the steady-state infusion.
Plasma drug concentrations of CAZ and AVI will be measured after the steady-state infusion
Population pharmacokinetic characterization and PK/PD-based dosing evaluation of CAZ-AVI
Time frame: After completion of pharmacokinetic data collection
Population pharmacokinetic models of ceftazidime and avibactam will be developed using plasma concentration and clinical data from critically ill patients. Pharmacokinetic/pharmacodynamic analyses will be performed to evaluate dosing regimens across different levels of renal function, including patients receiving renal replacement therapy (RRT).

6 secondary outcomes

Microbiological clearance
Time frame: 14 day after the onset of infection
Infection-related mortality
Time frame: 14 day after the onset of infection
Treatment outcome
Time frame: 14 day after the onset of infection
all-cause mortality
Time frame: 30 day after the onset of infection
length of stay
Time frame: Day 1 is defined as the day of confirmed diagnosis, the duration from confirmed diagnosis to ICU discharge will be measured.
length of stay
Time frame: From ICU admission to ICU discharge will be measured(assessed up to 120 days).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Individual participant dataSharing planned: No. Respect ethics and protect patient privacy

Related trials for Severe Sepsis

RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

YongHong Xiao, PhD study chair

First Affiliated Hospital of Zhejiang University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Sepsis and Carbapenem Resistant Bacterial Infection, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma drug concentrations of CAZ and AVI after first-dose administration (time frame: 0, 1, 2, 4, 6, and 8 hours after the first-dose infusion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.