Shandong Public Health Clinical Center
Jinan, China
Location status: Recruiting
Location contact
Qiang Zhang
CONTACT
Recruiting
NCT Number: NCT06711575
Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Anti-Infective Drugs
DrugAnti-infective drugs are administered using the traditional clinical dosing regimen, with no interventions.
Primary outcomes
-
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 outcomes
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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.
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erythrocyte sedimentation rate
Time frame: Through study completion, an average of 30 days
Clinical treatment outcome
-
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.
Sponsors and collaborators
Lead sponsor
Shandong University
Other
Collaborators
- Shandong Public Health Clinical Center
Registry information
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.