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

NCT06595979 | Recruiting

• 1 other identifier: 2024-0181
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 3

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.

Conditions

Intracranial Infections

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intracranial Administration Group

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

Drug: Polymyxin B

Intracranial Administration with IV Infusion Group

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

Drug: Polymyxin B

Interventions

Polymyxin B DRUG

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

Intracranial Administration Group; Intracranial Administration with IV Infusion Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Withdrawal Criteria: 1. Patient requests to withdraw from the study. 2. Patient's cerebrospinal fluid drug concentration results do not pass quality control center approval.

You may qualify if:

• Age ≥ 18 years old, regardless of gender.
• 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.
• 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.

You may not qualify if:

• Patients with known allergy to polymyxin B or other severe allergic histories that may affect the study.
• Pregnant women or other conditions that the investigator deems unsuitable for participation in the study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Ningbo Medical Center Lihuili Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (3)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315000, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Interventions

Polymyxin B

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Officials

• haibin dai, Doctorate

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

huifang jiang, master

CONTACT

+8613567147275; fangfang93@zju.edu.cn

yangmin hu, Master

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-06

Locations

CN (3)