Personalized ceftobiprole dosing for older adults guided by blood levels
Official title: Individualized Precision Therapy With Ceftobiprole Guided by PK/PD in Geriatric Populations
Run by Chinese PLA General Hospital · NCT07127185 · Data updated 2026-11-12
This study tests whether individualized dosing of ceftobiprole, guided by blood level measurements and patient factors, can improve treatment accuracy for people aged 60 and older.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | September 12, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07127185 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Individuals aged 60 years or older who are scheduled to receive ceftobiprole for more than 5 days and have not used ceftobiprole in the past month.
✕Probably not a fit
Patients with severe renal impairment requiring dialysis or those with BMI ≥ 30 kg/m² may not experience the same dosing benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study will enroll adults 60 years and older who are prescribed ceftobiprole. Researchers will measure drug concentrations in plasma using LC-MS/MS and collect patient characteristics such as age, weight, and kidney function. They will build a population pharmacokinetic model with Bayesian forecasting to describe how the drug behaves in the elderly and identify factors that cause variability. Dosing recommendations will be explored based on pathogen MIC values to tailor regimens to each patient. The goal is to optimize efficacy while minimizing toxicity in this population.
Why it matters
Potential benefit: If successful, dosing could be more precise for elderly patients, potentially improving effectiveness and reducing adverse effects.
How similar studies have gone: Previous pharmacokinetic and therapeutic drug monitoring work with cephalosporins supports this approach, though its elderly-specific model for ceftobiprole is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Chinese PLA General Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: He Jiong Wu
- Email: wujionghe1995@163.com
- Phone: 010-876250
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.