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NCT Number: NCT06729619

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. The incidence of adverse events caused by treatment

    Time frame: 2023-2026

    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.

  2. Treatment outcome of central infection

    Time frame: 2023-2026

    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.

Sponsors and collaborators

Lead sponsor

Xueyan Cui

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Dec 11, 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.