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

November 29, 2024 updated by: Wei Zhao, Shandong University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Jinan, China
        • Recruiting
        • Shandong Public Health Clinical Center
        • Contact:
          • Qiang Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clearance (L/h)
Time Frame: Through study completion, an average of 30 days
Through study completion, an average of 30 days
Volume of Distribution (L)
Time Frame: Through study completion, an average of 30 days
Through study completion, an average of 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the ratio of the area under the concentration-time curve from 0 to 24 hours
Time Frame: 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.
Through study completion, an average of 30 days
erythrocyte sedimentation rate
Time Frame: Through study completion, an average of 30 days
Clinical treatment outcome
Through study completion, an average of 30 days
Adverse events
Time Frame: Through study completion, an average of 30 days
Through study completion, an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Shandong Public Health Clinical Center

Investigators

  • Principal Investigator: Wei Zhao, Ph.D, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDU-2024-IDS-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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