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NCT Number: NCT06711562

Model-informed Individualized Treatment of Anti-infective Drugs

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.

Recruiting

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Key information

Conditions

Osteoarticular Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Public Health Clinical Center

Jinan, China

Location status: Recruiting

Location contact

Qiang Zhang

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Anti-Infective Drugs

Drug

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

Primary outcomes

  1. Clearance (L/h)

    Time frame: Through study completion, an average of 30 days

  2. Volume of Distribution (L)

    Time frame: Through study completion, an average of 30 days

Secondary outcomes

  1. 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.

  2. erythrocyte sedimentation rate

    Time frame: Through study completion, an average of 30 days

    Clinical treatment outcome

  3. Adverse events

    Time frame: Through study completion, an average of 30 days

Study contacts

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

Wei Zhao, Ph.D

CONTACT

[email protected]

86053188383308

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

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.

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