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临床试验/NCT07127185
NCT07127185招募中不适用

Individualized Precision Therapy With Ceftobiprole Guided by PK/PD in Geriatric Populations

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年9月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Ceftobiprole Concentration

研究概览

简要总结

Ceftobiprole, a fifth-generation cephalosporin, exhibits potent antibacterial activity against MRSA, penicillin-resistant Streptococcus pneumoniae (PRSP), and certain Gram-negative bacteria (e.g., Pseudomonas aeruginosa). 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 ceftobiprole 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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) Obese patients with body mass index (BMI) ≥30 kg/m²

研究组 & 干预措施

Ceftobiprole

Clinical Blood Sampling Protocol for Ceftobiprole in Geriatric Patients: Elderly patients received intravenous ceftobiprole (250 mg or 500 mg) every 12 hours, with infusion durations of 1 h, 1.5 h, or 2 h. After 3 days of antibiotic therapy (steady-state achievement), blood sampling was performed as follows:

Trough Concentration: A 3-mL 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°C and analyzed within 1 week of collection via liquid chromatography-tandem mass spectrometry (LC-MS/MS).

干预措施: LS/MS (Diagnostic Test)

结局指标

主要结局

Ceftobiprole Concentration

时间窗: after 3 days of antibiotic therapy

Plasma Ceftobiprole Concentration and Urinary Ceftobiprole Concentration

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Jionghui

Dr.

Chinese PLA General Hospital

研究点 (1)

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