Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations

NCT07494981 | Not Yet Recruiting DMC

• 1 other identifier: S2025-448-02
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Ceftazidime-avibactam Concentration

  Plasma Ceftobiprole Concentration and Urinary Ceftazidime-avibactam Concentration

  after 3 days of antibiotic therapy

Study Arms (1)

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).

Diagnostic Test: liquid chromatography-tandem mass spectrometry

Interventions

liquid chromatography-tandem mass spectrometry DIAGNOSTIC_TEST

Quantitative determination of ceftazidime-avibactam concentrations in plasma and urine was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Ceftazidime-avibactam

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Professional Translation for Clinical Research Protocols: Enroll patients aged ≥60 years receiving ceftazidime-avibactam therapy at Chinese PLA General Hospital

You may qualify if:

• Aged ≥60 years Scheduled to receive ceftazidime-avibactam therapy for \>5 days No prior ceftazidime-avibactam use within 1 month before enrollment

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Central Study Contacts

Yaping Yuan Clinical Professor

CONTACT

010-876250; yuanyp301@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 27, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share