Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB

Recruiting

• Conditions: Intracranial Infections
• Interventions: Drug: Polymyxin B

• Registration Number: NCT06595979
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-25
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 222

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intracranial Administration Group	Polymyxin B	Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.
Intracranial Administration with IV Infusion Group	Polymyxin B	Participants in this group will receive polymyxin B both intracranially and via intravenous infusion.

Primary Outcome Measures

Name	Time	Method
30-Day All-Cause Mortality Rate	30 days from the start of treatment	The proportion of participants who die from any cause within 30 days of treatment initiation. This measure will help evaluate the overall survival impact of the treatment methods.
CSF Bacterial Clearance	Baseline, 1 week, 2 weeks, and 30 days after initiation of treatment.	The rate at which bacteria are cleared from the cerebrospinal fluid (CSF). This will be assessed through CSF cultures and laboratory tests at designated time points to determine the effectiveness of the intervention in eradicating the infection.
Clinical Cure Rate	At the end of treatment (defined as the last day of the planned treatment regimen) and 30 days post-treatment	The proportion of participants who achieve clinical cure, defined as the resolution of symptoms and signs of infection, assessed by clinical examination and relevant diagnostic criteria at the end of the study or follow-up period.

Trial Locations

Locations (3)

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Ningbo Medical Center Lihuili Hospital; 🇨🇳 Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China