Intracranial InfectionsNCT06595979
Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB
An observational study of Intracranial Infections, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Infections
- What is being tested?
- Polymyxin B
- Type of treatment
- Injection or infusion
- How many people
- 222 participants
- Where
- 3 sitesChina
- Study dates
- 25 Jun 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
yangmin hu, Master contact
China3 sites, 3 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
huifang jiang, master, fangfang93@zju.edu.cn
haibi haibindai@zju.edu.cn, Doctorate
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
hua zhou, Bachelor, htzh85@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
lufeng hu, Doctor, hulufeng@163.com
About this study
Official title: 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.
- Conditions
- Intracranial Infections
- Being tested
- Polymyxin B
- Keywords
- Polymyxin B, Intracranial Administration, Carbapenem-Resistant Gram-Negative Bacteria, Intracranial infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymyxin BDrug
Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Administration Group | Participants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion. Receives: Drug: Polymyxin B | |
| Intracranial Administration with IV Infusion Group | Participants in this group will receive polymyxin B both intracranially and via intravenous infusion. Receives: Drug: Polymyxin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the end of treatment (defined as the last day of the planned treatment regimen) and 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial InfectionsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- haibin dai, Doctorate, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595979
- Sponsor's protocol ID
- 2024-0181
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intracranial Versus Intracranial Plus Intravenous Administration of Polymyxin B for the Treatment of Intracranial Infections Due to CRGNB
- ClinicalTrials.gov ID
- NCT06595979
- Acronym / sponsor ID
- 2024-0181
- Conditions
- Intracranial Infections
- Keywords
- Polymyxin B, Intracranial Administration, Carbapenem-Resistant Gram-Negative Bacteria, Intracranial infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracranial Administration Group | – | Drug: Polymyxin BParticipants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion. |
| Intracranial Administration with IV Infusion Group | – | Drug: Polymyxin BParticipants in this group will receive polymyxin B both intracranially and via intravenous infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymyxin BParticipants in this group will receive polymyxin B administered directly into the brain (intracranial administration) without intravenous (IV) infusion. | Drug | Intracranial Administration Group, Intracranial Administration with IV Infusion Group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yangmin hu, Master contact
haibin dai, Doctorate principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Infections, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact huifang jiang, master (+8613567147275, fangfang93@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day All-Cause Mortality Rate (time frame: 30 days from the start of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.