Clinical trial NCT06729619: Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application
Official title: Concentration Monitoring of Anti-infective Drugs in Human Cerebrospinal Fluid and Its Clinical Application
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Infection
Central Infection
Keywords: Intracranial infection
Cerebrospinal fluid concentration
Anti-infective drugs
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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, \&amp;lt; 50%; High protein, \&amp;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.

Primary outcomes:
measure: Cerebrospinal fluid concentration of anti-infective drugs
timeFrame: 2023-2026
Secondary outcomes:
measure: The incidence of adverse events caused by treatment
timeFrame: 2023-2026
measure: Treatment outcome of central infection
timeFrame: 2023-2026
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong Provincial
Study officials:
References: