Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections

Recruiting

• Conditions: Infectious Diseases of Spine

• Registration Number: NCT06711575
• Lead Sponsor: Shandong University

Brief Summary

The purpose of this study is to describe the population pharmacokinetic characteristics in patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy, and to evaluate effectiveness and safety of these drugs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-12
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients with suspected/confirmed spinal 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clearance (L/h)	Through study completion, an average of 30 days
Volume of Distribution (L)	Through study completion, an average of 30 days

Secondary Outcome Measures

Name	Time	Method
the ratio of the area under the concentration-time curve from 0 to 24 hours	Through study completion, an average of 30 days	For 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 rate	Through study completion, an average of 30 days	Clinical treatment outcome
Adverse events	Through study completion, an average of 30 days

Trial Locations

Locations (1)

Shandong Public Health Clinical Center; 🇨🇳 Jinan, China