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出境医 / 临床实验 / The Clinical Character,Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.

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

Study Description
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.

Condition or disease
Intracranial Infections Ventriculitis Meningitis Gram-Positive Bacterial Infections Gram-Negative Bacterial Infections Neurosurgery

Detailed 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.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Clinical Character,Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
Estimated Study Start Date : June 10, 2021
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : October 30, 2021
Arms and Interventions
Group/Cohort
Gram-negative bacteria group
Gram-negative bacteria intracranial infection after neurosurgery
Gram-positive bacteria group
Gram-positive bacteria intracranial infection after neurosurgery
Outcome Measures
Primary Outcome Measures :
  1. mortality [ Time Frame: 28 day mortality ]
    all-cause mortality


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability 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.
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: 林林 杜, PhD 13738120095 dulinlin@zju.edu.cn

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Layout table for investigator information
Study Director: 巍 崔, MD 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 8, 2021
Last Update Posted Date June 8, 2021
Estimated Study Start Date June 10, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2021)
mortality [ Time Frame: 28 day mortality ]
all-cause mortality
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Clinical Character,Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
Official Title The Clinical Character,Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability 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.
Condition
  • Intracranial Infections
  • Ventriculitis
  • Meningitis
  • Gram-Positive Bacterial Infections
  • Gram-Negative Bacterial Infections
  • Neurosurgery
Intervention Not Provided
Study Groups/Cohorts
  • Gram-negative bacteria group
    Gram-negative bacteria intracranial infection after neurosurgery
  • Gram-positive bacteria group
    Gram-positive bacteria intracranial infection after neurosurgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 2, 2021)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 30, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: 林林 杜, PhD 13738120095 dulinlin@zju.edu.cn
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04917380
Other Study ID Numbers 2021-0335
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Not Provided
Investigators
Study Director: 巍 崔, MD 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date June 2021