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

NCT ID: NCT06729619

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-03

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Intracranial Infection Central Infection

Keywords

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Intracranial infection Cerebrospinal fluid concentration Anti-infective drugs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with central infection

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

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xueyan Cui

OTHER

Sponsor Role lead

Responsible Party

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Xueyan Cui

associate professor of pharmacy

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shandong Provincial Qianfoshan Hospital

Jinan, Shandong Provincial, China

Site Status

Countries

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China

Other Identifiers

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QFS-CXY-2023-ZSGR-001

Identifier Type: -

Identifier Source: org_study_id