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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorShandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant/lactating women.

There are other factors that the researchers think are not suitable for inclusion

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Anti-Infective Drugs

    Drug

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

Treatment groups

No treatment groups listed

Trial outcomes

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

the ratio of the area under the concentration-time curve from 0 to 24 hours

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.

Time frame
Through study completion, an average of 30 days
2

erythrocyte sedimentation rate

Clinical treatment outcome

Time frame
Through study completion, an average of 30 days
3

Adverse events

Time frame
Through study completion, an average of 30 days

Other outcomes

Sponsors and contacts

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Shandong University

Lead sponsor

Shandong Public Health Clinical Center

Collaborator