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| Name | Class |
|---|---|
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracranial Administration Group | Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion. |
| |
| Intracranial Administration with IV Infusion Group | Participants in this group will receive polymyxin B both intracranially and via intravenous infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymyxin B | Drug | Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | At the end of treatment (defined as the last day of the planned treatment regimen) and 30 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Withdrawal Criteria:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| huifang jiang, master | Contact | +8613567147275 | fangfang93@zju.edu.cn | |
| yangmin hu, Master | Contact |
| Name | Affiliation | Role |
|---|---|---|
| haibin dai, Doctorate | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D011112 | Polymyxin B |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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Biological samples, such as cerebrospinal fluid (CSF) , will be collected for analysis during the study. These samples will not be used for DNA extraction or genetic testing.
| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | 315000 | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| D055666 |
| Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |