Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Cerebrospinal fluid concentration of anti-infective drugs
Study Overview
Brief Summary
At least 50 patients with intracranial infection receiving anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime and avibactam were included in each group for pharmacokinetic study, and the outcomes and adverse events of intracranial infection treatment were observed.
Detailed Description
This study intends to establish a high performance liquid phase method to determine the concentration of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam, ceftazidime abvibactam and other anti-infective drugs in cerebrospinal fluid, determine the concentration of cerebrospinal fluid in patients with central infection, and simultaneously determine the concentration of blood drugs at the same time point, optimize the clinical treatment plan by combining the concentration of cerebrospinal fluid and blood drugs, and explore the optimal concentration range of cerebrospinal fluid. At the same time, it can improve the cure rate of central infection, shorten the course of treatment and reduce the occurrence of adverse reactions.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years old;
- •clinically diagnosed as central infection (cerebrospinal fluid culture is positive with clinical infection symptoms) or suspected as central infection (abnormal cerebrospinal fluid examination, such as hypoglycemia, < 50%; High protein, > 50 mg/dl; The number of cells increased with clinical infection symptoms, but no cerebrospinal fluid culture was positive)
- •receiving anti-infection treatment such as vancomycin or meropenem or linezolid or cefoperazone sulbactam;
- •Sign the informed consent form.
Exclusion Criteria
- •There is no cerebrospinal fluid to determine the concentration;
- •allergic to drugs;
- •Other factors that researchers think are not suitable for inclusion.
Arms & Interventions
Patients with central infection
Intervention: The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined. (Drug)
Outcomes
Primary Outcomes
Cerebrospinal fluid concentration of anti-infective drugs
Time Frame: 2023-2026
We will establish a methodology for determining the concentrations of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam and ceftazidime ababactam in cerebrospinal fluid by high performance liquid chromatography, and determine the drug concentrations in cerebrospinal fluid of patients with central infection, and simultaneously determine the blood drug concentrations at the same time point.
Secondary Outcomes
- The incidence of adverse events caused by treatment(2023-2026)
- Treatment outcome of central infection(2023-2026)
Investigators
Xueyan Cui
associate professor of pharmacy
Qianfoshan Hospital