The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.

Meningitis Clinical Trial

Official title:

The Clinical Character，Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04917380
• Other study ID #: 2021-0335
• Status: Not yet recruiting
• Start date: June 10, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: ?? ?, PhD
• Phone: 13738120095
• Email: dulinlin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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%. 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.

Description:

1. To study the epidemiological distribution of pathogenic bacteria of intracranial infection after neurosurgery.

2. To study the risk factors of intracranial infection after neurosurgery (operations, type of external drainage tube, days of drainage tube , etc.).

3. To compare differences in clinical character，risks , treatment options, prognostic indicators between G+ bacterial infection group and G-infected bacterial group after neurosurgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 30, 2021
• Est. primary completion date: August 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• (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.

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-Negative Bacterial Infections
• Gram-Positive Bacterial Infections
• Infection
• Meningitis
• Neurosurgery
• Ventriculitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	all-cause mortality	28 day mortality