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NCT Number: NCT07127185

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

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LS/MS

Diagnostic Test

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

Primary outcomes

  1. Ceftobiprole Concentration

    Time frame: after 3 days of antibiotic therapy

    Plasma Ceftobiprole Concentration and Urinary Ceftobiprole Concentration

Study contacts

Contact information is provided by the study sponsor or research team.

He Jiong Wu

CONTACT

[email protected]

010-876250

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 17, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.