Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polymyxin B.
- Who it may be relevant to
- Registry conditions: Intracranial Infections. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Intracranial Versus Intracranial Plus Intravenous Administration of Polymyxin B for the Treatment of Intracranial Infections Due to CRGNB
Overview
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.
Interventions
- Drug Polymyxin B
Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.
Primary outcome measures
- 30-Day All-Cause Mortality Rate [Time frame: 30 days from the start of treatment]
- CSF Bacterial Clearance [Time frame: Baseline, 1 week, 2 weeks, and 30 days after initiation of treatment.]
- Clinical Cure Rate [Time frame: At the end of treatment (defined as the last day of the planned treatment regimen) and 30 days post-treatment]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old, regardless of gender.
- 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.
- 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
- Patients with known allergy to polymyxin B or other severe allergic histories that may affect the study.
- Pregnant women or other conditions that the investigator deems unsuitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
- Ningbo Medical Center Lihuili Hospital — Ningbo
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
Identifiers
NCT: NCT06595979 · 2024-0181