NCT06595979

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

Comparison of Intracranial Versus Intracranial Plus Intravenous Administration of Polymyxin B for the Treatment of Intracranial Infections Due to CRGNB

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 222 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Intracranial Infections

Interventions

Type	Name	Description
DRUG	Polymyxin B	Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.

Timeline

• Start date: 2024-06-25
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

3 sites across 1 country: China