Comparing two methods of administering polymyxin B for brain infections caused by resistant bacteria
Comparison of Intracranial Versus Intracranial Plus Intravenous Administration of Polymyxin B for the Treatment of Intracranial Infections Due to CRGNB
This study is testing two ways to give polymyxin B to people with severe brain infections caused by tough-to-treat bacteria to see which method works better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 222 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 3 sites (Hangzhou, Zhejiang and 2 other locations) |
| Trial ID | NCT06595979 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different methods for administering polymyxin B in patients suffering from severe brain infections caused by carbapenem-resistant Gram-negative bacteria (CRGNB). The study will compare direct intracranial administration of polymyxin B with a combination of this method and intravenous infusion. Participants will be monitored for treatment effectiveness, safety, and the concentration of polymyxin B in the cerebrospinal fluid (CSF). The goal is to identify the most effective treatment strategy for these challenging infections.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed intracranial infections caused by carbapenem-resistant Gram-negative bacteria and currently receiving polymyxin B treatment.
Not a fit: Patients with known allergies to polymyxin B or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with severe brain infections caused by resistant bacteria.
How similar studies have performed: While there have been studies on polymyxin B, this specific approach of comparing intracranial versus intravenous administration is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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.
Where this trial is running
Hangzhou, Zhejiang and 2 other locations
- The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Recruiting)
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: haibin dai, Doctorate — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: huifang jiang, master
- Email: fangfang93@zju.edu.cn
- Phone: +8613567147275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.