Actively Recruiting
Comparison of Intracranial Versus Intracranial Plus Intravenous Administration of Polymyxin B for Treating Brain Infections Caused by Carbapenem-Resistant Gram-Negative Bacteria
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-09-19
222
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
N
Ningbo Medical Center Lihuili Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two ways of giving polymyxin B to treat severe brain infections caused by carbapenem-resistant Gram-negative bacteria (CRGNB). The study looks at whether injecting the drug directly into the brain alone or combining this with an intravenous infusion works better to clear the infection and improve patient outcomes. It also measures the levels of polymyxin B in the cerebrospinal fluid (CSF) to understand how the drug acts in the body. Participants are divided into two groups. One group receives polymyxin B directly into the brain without an IV infusion. The other group receives polymyxin B both directly into the brain and through an IV infusion. All participants have an external ventricular drain to continuously drain CSF, and they must have been receiving polymyxin B treatment for at least five days before joining. During the study, researchers will monitor the 30-day mortality rate, bacterial clearance in the CSF at baseline, 1 week, 2 weeks, and 30 days after starting treatment, and the clinical cure rate at the end of treatment and 30 days afterward. Participants will be followed closely to assess how well the infection clears and to check safety. The study will continue until December 2026.
CONDITIONS
Brief Title
Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Cerebrospinal fluid cultures showing carbapenem-resistant Gram-negative bacteria with polymyxin MIC 64 0.5 bcg/ml
- Diagnosed with intracranial infection
- Receiving polymyxin B treatment for at least 5 days
- External ventricular drain in place for continuous drainage
You will not qualify if you...
- Known allergy to polymyxin B or severe allergic history
- Pregnant women
- Conditions deemed unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 5 days
Participants receive polymyxin B administered either directly into the brain or both intracranially and via intravenous infusion to treat intracranial infections caused by carbapenem-resistant Gram-negative bacteria.
Visits at baseline, 1 week, 2 weeks, and end of treatment
Duration - 30 days post-treatment
Participants are monitored for clinical cure and bacterial clearance up to 30 days after the end of treatment.
1 visit at 30 days post-treatment
Trial Site Locations
Total: 3 locations
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315000
Actively Recruiting
3
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
H
huifang jiang, master
Y
yangmin hu, Master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Frequently Asked Questions
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