Condition or disease |
---|
Intracranial Infections Ventriculitis Meningitis Gram-Positive Bacterial Infections Gram-Negative Bacterial Infections Neurosurgery |
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 |
Group/Cohort |
---|
Gram-negative bacteria group
Gram-negative bacteria intracranial infection after neurosurgery
|
Gram-positive bacteria group
Gram-positive bacteria intracranial infection after neurosurgery
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients diagnosed with intracranial infection after surgery and positive pathogenic microorganisms cultured in cerebrospinal fluid
Exclusion Criteria:
Contact: 林林 杜, PhD | 13738120095 | dulinlin@zju.edu.cn |
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 |
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 |
|
||||
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 |
|
||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
|
||||
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 |
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:
|
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts |
|
||||
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 |
|
||||
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 |
|
||||
PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
Verification Date | June 2021 |