Clinical trial NCT06595979: Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB
Official title: Comparison of Intracranial Versus Intracranial Plus Intravenous Administration of Polymyxin B for the Treatment of Intracranial Infections Due to CRGNB
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Infections
Keywords: Polymyxin B
Intracranial Administration
Carbapenem-Resistant Gram-Negative Bacteria
Intracranial infection
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Ningbo Medical Center Lihuili Hospital
name: First Affiliated Hospital of Wenzhou Medical University
First posted: 2024-09-19
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Withdrawal Criteria:

1. Patient requests to withdraw from the study.
2. Patient's cerebrospinal fluid drug concentration results do not pass quality control center approval.

Brief summary: This clinical trial aims to compare two methods of administering polymyxin B for treating severe brain infections caused by carbapenem-resistant Gram-negative bacteria (CRGNB). The two methods are: 1) delivering polymyxin B directly into the brain (intracranial administration) and 2) combining this with an intravenous (IV) infusion. The goal is to determine which approach is more effective in clearing the infection, improving patient outcomes, and influencing the concentration of polymyxin B in the cerebrospinal fluid (CSF). Participants in this study will be monitored for both effectiveness and safety, with a focus on CSF polymyxin B levels, to find the best treatment strategy for these challenging infections.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender.
2. Patients with cerebrospinal fluid (CSF) cultures showing carbapenem-resistant Gram-negative bacteria (such as Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa) and polymyxin MIC ≤ 0.5 µg/ml.
3. Diagnosed with intracranial infection and have been receiving polymyxin B treatment for at least 5 days, with an external ventricular drain (EVD) in place for continuous drainage.

Exclusion Criteria:

1. Patients with known allergy to polymyxin B or other severe allergic histories that may affect the study.
2. Pregnant women or other conditions that the investigator deems unsuitable for participation in the study.

Primary outcomes:
measure: 30-Day All-Cause Mortality Rate
timeFrame: 30 days from the start of treatment
measure: CSF Bacterial Clearance
timeFrame: Baseline, 1 week, 2 weeks, and 30 days after initiation of treatment.
measure: Clinical Cure Rate
timeFrame: At the end of treatment (defined as the last day of the planned treatment regimen) and 30 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: haibin dai, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: