Ceftazidime-avibactamNCT07494981
Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations
An observational study of Ceftazidime-avibactam, run by Chinese PLA General Hospital.
Trial summary
Ceftazidime-avibactam is a β-lactam/β-lactamase inhibitor combination treatment which has been developed to address infections caused by ESBL-, AmpC- and serine carbapenemase-producing Gram-negative bacteria. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ceftazidime-avibactam
- What is being tested?
- liquid chromatography-tandem mass spectrometry
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2026to 31 Dec 2030
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professional Translation for Clinical Research Protocols: Enroll patients aged ≥60 years receiving ceftazidime-avibactam therapy at Chinese PLA General Hospital
Who may be able to join
- Aged ≥60 years Scheduled to receive ceftazidime-avibactam therapy for >5 days No prior ceftazidime-avibactam use within 1 month before enrollment
Who cannot join
- Patients requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or continuous renal replacement therapy [CRRT]) or with renal impairment history (nephrectomy, renal transplantation, solitary kidney, uremia)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Ceftazidime-avibactam is a β-lactam/β-lactamase inhibitor combination treatment which has been developed to address infections caused by ESBL-, AmpC- and serine carbapenemase-producing Gram-negative bacteria. In elderly patients, significant interindividual variability often leads to inappropriate dosing (subtherapeutic or excessive), compromising efficacy or increasing toxicity risks. This prospective, multicenter study will enroll patients aged ≥60 years receiving ceftobiprole. Using LC-MS/MS for therapeutic drug monitoring (TDM), we will measure plasma concentrations and integrate individual characteristics (age, body weight, creatinine clearance, etc.). Population pharmacokinetic (PPK) modeling with Bayesian forecasting will be employed to estimate individual PK parameters and identify covariates influencing variability, thereby establishing a PPK model for ceftazidime-avibactam in the elderly.
Based on pathogen-specific MIC values, dosing regimens (dose, frequency) will be dynamically optimized to guide precision therapy. Subsequent TDM data will continuously refine the PPK model, creating a self-optimizing system. This framework lays the groundwork for extending individualized treatment strategies to other antimicrobials in geriatric populations.
- Conditions
- Ceftazidime-avibactam
- Being tested
- liquid chromatography-tandem mass spectrometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid chromatography-tandem mass spectrometryDiagnostic test
Quantitative determination of ceftazidime-avibactam concentrations in plasma and urine was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
| Study group | Role | What they receive |
|---|---|---|
| Ceftazidime-avibactam | Clinical Blood Sampling Protocol for Ceftazidime-avibactam in Geriatric Patients: Elderly patients received intravenous ceftobiprole, with infusion durations of 1h, 1.5h, or 2h. After 3days of antibiotic therapy (steady-state achievement), blood sampling was performed as follows:
Trough Concentration: A 3mL peripheral blood sample was collected from the antecubital vein pre-dose (before the next scheduled administration) using EDTA-containing Vacutainers®.
Peak Concentration: A blood sample was drawn immediately after completion of the intravenous infusion. All blood specimens were centrifuged at 2500×g for 10 minutes. Plasma samples were stored at -20℃ and analyzed within 1 week of collection via liquid chromatography-tandem mass spectrometry (LC-MS/MS). Receives: Diagnostic Test: liquid chromatography-tandem mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceftazidime-avibactam Concentration
Plasma Ceftobiprole Concentration and Urinary Ceftazidime-avibactam Concentration
Measured: after 3 days of antibiotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start25 Mar 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ceftazidime-avibactamStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jionghe Wu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494981
- Sponsor's protocol ID
- S2025-448-02
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations
- ClinicalTrials.gov ID
- NCT07494981
- Acronym / sponsor ID
- S2025-448-02
- Conditions
- Ceftazidime-avibactam
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Mar 2026 (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.
Ceftazidime-avibactam is a β-lactam/β-lactamase inhibitor combination treatment which has been developed to address infections caused by ESBL-, AmpC- and serine carbapenemase-producing Gram-negative bacteria. In elderly patients, significant interindividual variability often leads to inappropriate dosing (subtherapeutic or excessive), compromising efficacy or increasing toxicity risks. This prospective, multicenter study will enroll patients aged ≥60 years receiving ceftobiprole. Using LC-MS/MS for therapeutic drug monitoring (TDM), we will measure plasma concentrations and integrate individual characteristics (age, body weight, creatinine clearance, etc.). Population pharmacokinetic (PPK) modeling with Bayesian forecasting will be employed to estimate individual PK parameters and identify covariates influencing variability, thereby establishing a PPK model for ceftazidime-avibactam in the elderly.
Based on pathogen-specific MIC values, dosing regimens (dose, frequency) will be dynamically optimized to guide precision therapy. Subsequent TDM data will continuously refine the PPK model, creating a self-optimizing system. This framework lays the groundwork for extending individualized treatment strategies to other antimicrobials in geriatric populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftazidime-avibactam | – | Diagnostic Test: liquid chromatography-tandem mass spectrometryClinical Blood Sampling Protocol for Ceftazidime-avibactam in Geriatric Patients: Elderly patients received intravenous ceftobiprole, with infusion durations of 1h, 1.5h, or 2h. After 3days of antibiotic therapy (steady-state achievement), blood sampling was performed as follows: Trough Concentration: A 3mL peripheral blood sample was collected from the antecubital vein pre-dose (before the next scheduled administration) using EDTA-containing Vacutainers®. Peak Concentration: A blood sample was drawn immediately after completion of the intravenous infusion. All blood specimens were centrifuged at 2500×g for 10 minutes. Plasma samples were stored at -20℃ and analyzed within 1 week of collection via liquid chromatography-tandem mass spectrometry (LC-MS/MS). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professional Translation for Clinical Research Protocols: Enroll patients aged ≥60 years receiving ceftazidime-avibactam therapy at Chinese PLA General Hospital
Key inclusion criteria (1 listed)
- Aged ≥60 years Scheduled to receive ceftazidime-avibactam therapy for >5 days No prior ceftazidime-avibactam use within 1 month before enrollment
Key exclusion criteria (1 listed)
- Patients requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or continuous renal replacement therapy [CRRT]) or with renal impairment history (nephrectomy, renal transplantation, solitary kidney, uremia)
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 |
|---|---|---|
| liquid chromatography-tandem mass spectrometryQuantitative determination of ceftazidime-avibactam concentrations in plasma and urine was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). | Diagnostic test | Ceftazidime-avibactam |
Primary outcome
Ceftazidime-avibactam Concentration
Time frame: after 3 days of antibiotic therapy
Plasma Ceftobiprole Concentration and Urinary Ceftazidime-avibactam Concentration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ceftazidime-avibactam, run by Chinese PLA General Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaping Yuan Clinical Professor (010-876250, yuanyp301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ceftazidime-avibactam Concentration (time frame: after 3 days of antibiotic therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.