NCT04917380

Brief 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%. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

June 2, 2021

Last Update Submit

June 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • mortality

    all-cause mortality

    28 day mortality

Study Arms (2)

Gram-negative bacteria group

Gram-negative bacteria intracranial infection after neurosurgery

Gram-positive bacteria group

Gram-positive bacteria intracranial infection after neurosurgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • \- Patients diagnosed with intracranial infection after surgery and positive pathogenic microorganisms cultured in cerebrospinal fluid

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MeningitisGram-Positive Bacterial InfectionsGram-Negative Bacterial Infections

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • 巍 崔, MD

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    STUDY DIRECTOR

Central Study Contacts

林林 杜, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

June 10, 2021

Primary Completion

August 30, 2021

Study Completion

October 30, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06