Ceftobiprole
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTLS/MS
Quantitative determination of ceftobiprole concentrations in plasma and urine was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ceftobiprole Concentration | after 3 days of antibiotic therapy | Plasma Ceftobiprole Concentration and Urinary Ceftobiprole Concentration |
Countries
China
Contacts
CONTACTHe Jiong Wu
Outcome results
None listed