Intracranial InfectionsNCT04917380
The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
An observational study of Intracranial Infections and Ventriculitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Intracranial infection is one of the common clinical complications after neurosurgery, especially after external cerebrospinal fluid drainage. Postoperative intracranial infection has a very high incidence, and its incidence is about 0.34%-3.1%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Infections, Ventriculitis, Meningitis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2021to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: A retrospective review of the Second Affiliated Hospital of Zhejiang University from January 2013 to May 2021, diagnosed patients with intracranial infection after surgery and positive for pathogenic microorganisms cultured in cerebrospinal fluid.
Who may be able to join
- Patients diagnosed with intracranial infection after surgery and positive pathogenic microorganisms cultured in cerebrospinal fluid
Who cannot join
- (1) < 18 years old, (2) Pregnant or lactating women, (3) fungus in CSF culture, (4) Clinical judgment is not intracranial infection, and CSF culture positive considers contaminating patients.
Trial locations and contacts
No sites are listed yet.
About this study
Intracranial infection is one of the common clinical complications after neurosurgery, especially after external cerebrospinal fluid drainage. Postoperative intracranial infection has a very high incidence, and its incidence is about 0.34%-3.1%. Once infection occurs, it will directly affect the length of hospitalization, mortality and disability of postoperative patients. The pathogenic bacteria of postoperative intracranial infections include G-bacteria and G+ bacteria, and fungi. Common G+ bacteria are Staphylococcus aureus. Common G-bacteria are Acinetobacter baumannii, Klebsiella pneumoniae, and Pseudomonas aeruginosa Bacteria, Escherichia coli and so on. In recent years, studies have reported that postoperative intracranial infections of G-bacteria are gradually increasing. In the previous study of our research group, it was found that Acinetobacter baumannii and Klebsiella pneumoniae accounted for the top two pathogens of postoperative intracranial infections in ICU. In particular, the proportion of carbapenem-resistant G-bacteria has increased, which brings difficulty and challenge to the treatment and seriously affects the prognosis of patients. Different pathogen infections may lead to different prognosis of patients with intracranial infection after neurosurgery. With different pathogens as the starting point, there are few studies comparing the clinical features, risk factors, and prognosis of intracranial infections after neurosurgery. Therefore, it is great significant to explore and understand different pathogenic bacteria, risk factors, drug resistance, treatment options, and prognosis after neurosurgery.
Read the detailed description
- To study the epidemiological distribution of pathogenic bacteria of intracranial infection after neurosurgery.
- To study the risk factors of intracranial infection after neurosurgery (operations, type of external drainage tube, days of drainage tube , etc.).
- To compare differences in clinical character，risks , treatment options, prognostic indicators between G+ bacterial infection group and G-infected bacterial group after neurosurgery.
- Conditions
- Intracranial Infections, Ventriculitis, Meningitis, Gram-Positive Bacterial Infections, Gram-Negative Bacterial Infections, Neurosurgery
- Medical subject headings
- Meningitis, Gram-Positive Bacterial Infections, Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Retrospective clinical study，no intervention
| Study group | Role | What they receive |
|---|---|---|
| Gram-negative bacteria group | Gram-negative bacteria intracranial infection after neurosurgery | |
| Gram-positive bacteria group | Gram-positive bacteria intracranial infection after neurosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
all-cause mortality
Measured: 28 day mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start10 Jun 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Oct 2021 (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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 巍 崔, MD, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917380
- Sponsor's protocol ID
- 2021-0335
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 8 Jun 2021
- 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
- ClinicalTrials.gov ID
- NCT04917380
- Acronym / sponsor ID
- 2021-0335
- Conditions
- Intracranial Infections, Ventriculitis, Meningitis, Gram-Positive Bacterial Infections, Gram-Negative Bacterial Infections, Neurosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Jun 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 8 Jun 2021 (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.
Intracranial infection is one of the common clinical complications after neurosurgery, especially after external cerebrospinal fluid drainage. Postoperative intracranial infection has a very high incidence, and its incidence is about 0.34%-3.1%. Once infection occurs, it will directly affect the length of hospitalization, mortality and disability of postoperative patients. The pathogenic bacteria of postoperative intracranial infections include G-bacteria and G+ bacteria, and fungi. Common G+ bacteria are Staphylococcus aureus. Common G-bacteria are Acinetobacter baumannii, Klebsiella pneumoniae, and Pseudomonas aeruginosa Bacteria, Escherichia coli and so on. In recent years, studies have reported that postoperative intracranial infections of G-bacteria are gradually increasing. In the previous study of our research group, it was found that Acinetobacter baumannii and Klebsiella pneumoniae accounted for the top two pathogens of postoperative intracranial infections in ICU. In particular, the proportion of carbapenem-resistant G-bacteria has increased, which brings difficulty and challenge to the treatment and seriously affects the prognosis of patients. Different pathogen infections may lead to different prognosis of patients with intracranial infection after neurosurgery. With different pathogens as the starting point, there are few studies comparing the clinical features, risk factors, and prognosis of intracranial infections after neurosurgery. Therefore, it is great significant to explore and understand different pathogenic bacteria, risk factors, drug resistance, treatment options, and prognosis after neurosurgery.
Detailed description
- To study the epidemiological distribution of pathogenic bacteria of intracranial infection after neurosurgery.
- To study the risk factors of intracranial infection after neurosurgery (operations, type of external drainage tube, days of drainage tube , etc.).
- To compare differences in clinical character，risks , treatment options, prognostic indicators between G+ bacterial infection group and G-infected bacterial group after neurosurgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gram-negative bacteria group | – | –Gram-negative bacteria intracranial infection after neurosurgery |
| Gram-positive bacteria group | – | –Gram-positive bacteria intracranial infection after neurosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A retrospective review of the Second Affiliated Hospital of Zhejiang University from January 2013 to May 2021, diagnosed patients with intracranial infection after surgery and positive for pathogenic microorganisms cultured in cerebrospinal fluid.
Key inclusion criteria (1 listed)
- Patients diagnosed with intracranial infection after surgery and positive pathogenic microorganisms cultured in cerebrospinal fluid
Key exclusion criteria (1 listed)
- (1) < 18 years old, (2) Pregnant or lactating women, (3) fungus in CSF culture, (4) Clinical judgment is not intracranial infection, and CSF culture positive considers contaminating patients.
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 |
|---|---|---|
| Retrospective clinical study，no intervention | Other | Gram-negative bacteria group, Gram-positive bacteria group |
Primary outcome
mortality
Time frame: 28 day mortality
all-cause mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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RecruitingObservational study
Intraventricular Administration of Intracranial Infections Caused by （Carbapenem-resistant Gram-negative Bacilli）CRGNB
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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. This study is not recruiting at the moment.
巍 崔, MD study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Infections and Ventriculitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 林林 杜, PhD (13738120095, dulinlin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28 day mortality). 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 8 Jun 2021.