Infectious Diseases of Spine
Conditions
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.
Interventions
Anti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions.
Sponsors
Shandong Public Health Clinical Center
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactWei Zhao, Ph.D
Outcome results
None listed