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Model-informed Individualized Treatment of Anti-infective Drugs

Model-informed Individualized Treatment of Anti-infective Drugs in Patients With Osteoarticular Infections

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06711562
Enrollment
300
Registered
2024-12-02
Start date
2024-10-12
Completion date
2026-10-01
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarticular Infections

Brief summary

The study aims to optimize individualized treatment of anti-infective drugs in osteoarticular infections by analyzing drug exposure in patients blood and/or tissues using population pharmacokinetics.

Interventions

Anti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions.

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with suspected/confirmed osteoarticular infections who are undergoing anti-infective drug therapy.

Exclusion criteria

* Pregnant/lactating women. * There are other factors that the researchers think are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Clearance (L/h)Through study completion, an average of 30 days
Volume of Distribution (L)Through study completion, an average of 30 days

Secondary

MeasureTime frameDescription
ratio of the area under the concentration-time curve from 0 to 24 hoursThrough study completion, an average of 30 daysFor time-dependent antimicrobials, the PD target is defined as the time of free drug concentration beyond MIC during the dose interval. For concentration-dependent antimicrobials, the PD target is defined as the ratio of the area under the concentration-time curve from 0 to 24 hours to the MIC.
erythrocyte sedimentation rateThrough study completion, an average of 30 daysClinical treatment outcome
Adverse eventsThrough study completion, an average of 30 days

Countries

China

Contacts

Primary ContactWei Zhao, Ph.D
zhao4wei2@hotmail.com86053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026