Recruiting NCT06711575
Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anti-Infective Drugs.
- Who it may be relevant to
- Registry conditions: Infectious Diseases of Spine. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Anti-Infective Drugs
Anti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions.
Primary outcome measures
- Clearance (L/h) [Time frame: Through study completion, an average of 30 days]
- Volume of Distribution (L) [Time frame: Through study completion, an average of 30 days]
Secondary outcome measures (3)
- 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]
- erythrocyte sedimentation rate [Time frame: Through study completion, an average of 30 days]
- Adverse events [Time frame: Through study completion, an average of 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shandong Public Health Clinical Center — Jinan
Identifiers
NCT: NCT06711575 · SDU-2024-IDS-006