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

Recruitingn/aAges 60 Years - anyAllChinese PLA General Hospital
NCT07127185 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged ≥60 years Scheduled to receive ceftobiprole therapy for \>5 days No prior ceftobiprole use within 1 month before enrollment Exclusion Criteria: * 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
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What it tests

  • LS/MS
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Where

1 site
Chinese PLA General Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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