CeftobiproleNCT07127185
Individualized Precision Therapy With Ceftobiprole Guided by PK/PD in Geriatric Populations
An observational study of Ceftobiprole, run by Chinese PLA General Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ceftobiprole
- What is being tested?
- LS/MS
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to 31 Dec 2029
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Professional Translation for Clinical Research Protocols: Enroll patients aged ≥60 years receiving ceftobiprole therapy at Chinese PLA General Hospital
Who may be able to join
- Aged ≥60 years Scheduled to receive ceftobiprole therapy for >5 days No prior ceftobiprole use within 1 month before enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Jionghe Wu, 19910178301, wujionghe1995@163.com
Jionghe Wu, wujionghe1995@163.com
About this study
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.
- Conditions
- Ceftobiprole
- Being tested
- LS/MS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS/MSDiagnostic test
Quantitative determination of ceftobiprole concentrations in plasma and urine was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: LS/MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceftobiprole Concentration
Plasma Ceftobiprole Concentration and Urinary Ceftobiprole Concentration
Measured: after 3 days of antibiotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start12 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CeftobiproleStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Jionghui, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127185
- Sponsor's protocol ID
- S2025-448-01
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unauthorized disclosure of the research protocol may undermine investigator motivation and compromise scientific validity.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Precision Therapy With Ceftobiprole Guided by PK/PD in Geriatric Populations
- ClinicalTrials.gov ID
- NCT07127185
- Acronym / sponsor ID
- S2025-448-01
- Conditions
- Ceftobiprole
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftobiprole | – | Diagnostic Test: LS/MSClinical 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Professional Translation for Clinical Research Protocols: Enroll patients aged ≥60 years receiving ceftobiprole therapy at Chinese PLA General Hospital
Key inclusion criteria (1 listed)
- Aged ≥60 years Scheduled to receive ceftobiprole therapy for >5 days No prior ceftobiprole use within 1 month before enrollment
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LS/MSQuantitative determination of ceftobiprole concentrations in plasma and urine was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). | Diagnostic test | Ceftobiprole |
Primary outcome
Ceftobiprole Concentration
Time frame: after 3 days of antibiotic therapy
Plasma Ceftobiprole Concentration and Urinary Ceftobiprole Concentration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Unauthorized disclosure of the research protocol may undermine investigator motivation and compromise scientific validity.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ceftobiprole, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Jiong Wu (010-876250, wujionghe1995@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ceftobiprole Concentration (time frame: after 3 days of antibiotic therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.