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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Infection; Central Infection
• Intervention / Treatment: Drug: The concentration of anti-infective drugs in blood and cerebrospinal fluid will be determined.

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Shandong Provincial
    • Jinan, Shandong Provincial, China, 250014
      • Shandong Provincial Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The sample size of patients with central infection was collected from November 2023 to the completion.

Recruitment location: First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province).

Research time: 2023-2026.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with central infection	Drug: The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2023-2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2023-2026

Collaborators and Investigators

• Sponsor: Xueyan Cui

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Anti-infective drugs; Intracranial infection; Cerebrospinal fluid concentration
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Anti-Infective Agents
• Other Study ID Numbers: QFS-CXY-2023-ZSGR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No