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

Zhejiang University

Status: Enrolling

Conditions: Intracranial Infections

Treatments: Drug: Polymyxin B

Study type: Observational

Funder types: Other

Identifiers

NCT06595979

2024-0181

Details and patient eligibility

About

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.

Enrollment: 222 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

222 participants in 2 patient groups

Intracranial Administration Group

Description:

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

Treatment:

Drug: Polymyxin B

Intracranial Administration with IV Infusion Group

Description:

Participants in this group will receive polymyxin B both intracranially and via intravenous infusion.

Treatment:

Drug: Polymyxin B