An observational study in Intracranial Infections, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 222 is close to the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Withdrawal Criteria:
Exclusion Criteria:
Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.
Drug: Polymyxin B
Participants in this group will receive polymyxin B both intracranially and via intravenous infusion.
Drug: Polymyxin B
Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.
30-Day All-Cause Mortality Rate
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.
Time frame: 30 days from the start of treatment
CSF Bacterial Clearance
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.
Time frame: Baseline, 1 week, 2 weeks, and 30 days after initiation of treatment.
Clinical Cure Rate
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.
Time frame: At the end of treatment (defined as the last day of the planned treatment regimen) and 30 days post-treatment
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Second Affiliated Hospital, School of Medicine, Zhejiang University