Status:
RECRUITING
Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Intracranial Infections
Eligibility:
All Genders
18-75 years
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT06595979
Start Date
June 25 2024
End Date
December 1 2026
Last Update
September 19 2024
Active Locations (3)
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1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
2
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315000
3
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000