Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB

Comparison of Intracranial Versus Intracranial Plus Intravenous Administration of Polymyxin B for the Treatment of Intracranial Infections Due to CRGNB

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06595979

Enrollment

222

Registered

2024-09-19

Start date

2024-06-25

Completion date

2026-12-31

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Infections

Keywords

Polymyxin B, Intracranial Administration, Carbapenem-Resistant Gram-Negative Bacteria, Intracranial infection

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) 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.

Interventions

DRUGPolymyxin B

Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
30-Day All-Cause Mortality Rate	30 days from the start of treatment	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.
CSF Bacterial Clearance	Baseline, 1 week, 2 weeks, and 30 days after initiation of treatment.	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.
Clinical Cure Rate	At the end of treatment (defined as the last day of the planned treatment regimen) and 30 days post-treatment	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.

Countries

China

Contacts

Primary Contacthuifang jiang, master

fangfang93@zju.edu.cn+8613567147275

Backup Contactyangmin hu, Master

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026