Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application

N/AActive Not RecruitingNCT06729619

Xueyan Cui200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Intracranial Infection Central Infection

Interventions

The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined.DRUG

Blood and cerebrospinal fluid concentrations of anti-infective drugs such as vancomycin, meropenem, linezolid, cefoperazone sulbactam and ceftazidime ababactam will be monitored after the drug reaches a steady state.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years old; 2. 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, \&lt; 50%; High protein, \&gt; 50 mg/dl; The number of cells increased with clinical infection symptoms, but no cerebrospinal fluid culture was positive) 3. receiving anti-infection treatment such as vancomycin or meropenem or linezolid or cefoperazone sulbactam; 4. Sign the informed consent form. Exclusion Criteria: 1. There is no cerebrospinal fluid to determine the concentration; 2. allergic to drugs; 3. Other factors that researchers think are not suitable for inclusion.

Locations (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, China

Outcomes

Primary Outcomes

Cerebrospinal fluid concentration of anti-infective drugs

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.

Time frame: 2023-2026

Secondary Outcomes

The incidence of adverse events caused by treatment

In a clinical trial, the probability of an unexpected and adverse medical event that occurs after a patient or clinical subject receives a trial drug, but it does not necessarily have a causal relationship with the treatment.

Time frame: 2023-2026

Treatment outcome of central infection

If there are blood routine tests, cerebrospinal fluid tests and procalcitonin tests before and after drug treatment, relevant information, combined drugs and adverse events will be collected to evaluate the effectiveness and safety of drug treatment for central infection.

Time frame: 2023-2026

Data from ClinicalTrials.gov

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