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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06729619
Enrollment
200
Registered
2024-12-11
Start date
2024-06-03
Completion date
2027-12-31
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Infection, Intracranial Infection

Keywords

Intracranial infection, Cerebrospinal fluid concentration, Anti-infective drugs

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.

Interventions

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

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.

Sponsors

Xueyan Cui
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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, < 50%; High protein, > 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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebrospinal fluid concentration of anti-infective drugs2023-2026We 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

MeasureTime frameDescription
Treatment outcome of central infection2023-2026If 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.
The incidence of adverse events caused by treatment2023-2026In 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026