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

September 11, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

222

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: yangmin hu, Master

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
        • Contact:
          • haibi haibindai@zju.edu.cn, Doctorate
      • Ningbo, Zhejiang, China, 315000
        • Recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Drug: Polymyxin B
Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Wenzhou Medical University

Investigators

  • Principal Investigator: haibin dai, Doctorate, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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