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出境医 / 临床实验 / Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis (KlebsieLCR)

Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis (KlebsieLCR)

Study Description
Brief Summary:
Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.

Condition or disease
Meningitis

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis
Actual Study Start Date : July 5, 2019
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Characterize meningitis with Klebsiella pneumoniae [ Time Frame: Day 1 ]
    This corresponds to characterize Klebsiella pneumoniae meningitis, portal entry, secondary infection, associated antibiotic and associated therapies and the clinical course of patients.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group between 2008 and 2018.
Criteria

Inclusion Criteria:

  • Man or Woman whose age ≥ 18 years
  • Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group
  • Francophone patient

Exclusion Criteria:

  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Patient under safeguard of justice
  • Patient opposing his participation
Contacts and Locations

Locations
Show Show 18 study locations
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Layout table for investigator information
Study Director: Benoit PILMIS, MD Groupe Hospitalier Paris Saint Joseph
Tracking Information
First Submitted Date May 24, 2019
First Posted Date May 30, 2019
Last Update Posted Date August 13, 2020
Actual Study Start Date July 5, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2019) 		Characterize meningitis with Klebsiella pneumoniae [ Time Frame: Day 1 ]
This corresponds to characterize Klebsiella pneumoniae meningitis, portal entry, secondary infection, associated antibiotic and associated therapies and the clinical course of patients.
Original Primary Outcome Measures Same as current
Change History
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 Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis
Official Title Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis
Brief Summary Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group between 2008 and 2018.
Condition Meningitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Active, not recruiting
Actual Enrollment
 (submitted: August 12, 2020) 		132
Original Estimated Enrollment
 (submitted: May 29, 2019) 		160
Estimated Study Completion Date September 30, 2021
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Man or Woman whose age ≥ 18 years
  • Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group
  • Francophone patient

Exclusion Criteria:

  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Patient under safeguard of justice
  • Patient opposing his participation
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967210
Other Study ID Numbers KlebsieLCR
Has Data Monitoring Committee No
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 Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators
Study Director: Benoit PILMIS, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date August 2020

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