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出境医 / 临床实验 / MICROBIOLOGY OF CEREBRAL ABSCESSES

MICROBIOLOGY OF CEREBRAL ABSCESSES

Study Description
Brief Summary:
Establish the repertoire of bacteria and Archaea responsible for brain abscesses. Correlate the microbial repertoire to epidemiological, clinical and radiological data; to define the different nosological entities falling within the framework of cerebral abscesses.

Condition or disease Intervention/treatment
Brain Abscess Other: Surgical puncture

Detailed Description:
Brain abscess is a fatal infectious pathology of the central nervous system for which our CHU provides a referent function and supports patients suspected and diagnosed with a cerebral abscess in the area of the regional hospital group (GHT). Through the routine activity of the Microbiology laboratory of the IHU Méditerranée Infection, more than 180 diagnosed patients have been investigated in 9 years, an average of 20 patients per year. The mortality of brain abscesses is currently measured at 15% despite well-established diagnostic and therapeutic protocols in the literature, associating surgical drainage of abscess and administration of probabilistic antibiotics. Our hypothesis is that established protocols take into account incomplete microbiological documentation of cerebral abscesses and therefore anti-infectious therapy that may not be strictly adapted to the causative microorganisms. Our hypothesis is based on our own work as well as the literature data, showing that current approaches only target bacteria but that these approaches leave aside other living worlds such as Archaea. Indeed, investigators have recently shown for the first time that methanogens, which are Archaea microorganisms, constitute part of the flora responsible for certain cerebral abscesses and that they have a direct pathogenic role in cerebral abscesses. More specifically, the diagnosis of cerebral abscess includes several clinical and microbiological situations that are not all of the same therapeutic. Investigator propose to collect 20 abscesses. A collection of abscesses is performed systematically during the diagnosis for bacteriological analysis. There will be no further examination. The main objective of this clinical research project is to establish the repertoire of microorganisms responsible for brain abscesses; and as a secondary objective to define the different clinical entities forming the cerebral abscesses.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MICROBIOLOGY OF CEREBRAL ABSCESSES (ABCES)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : October 30, 2023
Arms and Interventions
Group/Cohort Intervention/treatment
Patients with an abscess
Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
Other: Surgical puncture
Investigators propose to collect 20 abscesses. A collection of abscesses is performed systematically during the diagnostic for bacteriological analysis. There will be no further examination.

Outcome Measures
Primary Outcome Measures :
  1. Matrix Assisted Laser Desorption Ionisation - Time of Flight [ Time Frame: 1 day ]
    A matrix and a sample are deposited on a target. Pulsed lasers are fast charging.


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:   Probability Sample
Study Population
Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
Criteria

Inclusion Criteria:

  • Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
  • Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

  • Pregnant or nursing woman.
  • Major patient under tutorship or curatorship.
  • Patient deprived of liberty or under a court order
  • Patient refusing to participate in the study
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Didier Raoult 04 13 73 20 51 didier.raoult@gmail.com
Contact: Alexandra Giuliani 04 91 38 28 70 promotion.interne@aphm.fr

Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Tracking Information
First Submitted Date July 9, 2019
First Posted Date July 12, 2019
Last Update Posted Date July 16, 2019
Estimated Study Start Date October 1, 2019
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2019)
Matrix Assisted Laser Desorption Ionisation - Time of Flight [ Time Frame: 1 day ]
A matrix and a sample are deposited on a target. Pulsed lasers are fast charging.
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 MICROBIOLOGY OF CEREBRAL ABSCESSES
Official Title MICROBIOLOGY OF CEREBRAL ABSCESSES (ABCES)
Brief Summary Establish the repertoire of bacteria and Archaea responsible for brain abscesses. Correlate the microbial repertoire to epidemiological, clinical and radiological data; to define the different nosological entities falling within the framework of cerebral abscesses.
Detailed Description Brain abscess is a fatal infectious pathology of the central nervous system for which our CHU provides a referent function and supports patients suspected and diagnosed with a cerebral abscess in the area of the regional hospital group (GHT). Through the routine activity of the Microbiology laboratory of the IHU Méditerranée Infection, more than 180 diagnosed patients have been investigated in 9 years, an average of 20 patients per year. The mortality of brain abscesses is currently measured at 15% despite well-established diagnostic and therapeutic protocols in the literature, associating surgical drainage of abscess and administration of probabilistic antibiotics. Our hypothesis is that established protocols take into account incomplete microbiological documentation of cerebral abscesses and therefore anti-infectious therapy that may not be strictly adapted to the causative microorganisms. Our hypothesis is based on our own work as well as the literature data, showing that current approaches only target bacteria but that these approaches leave aside other living worlds such as Archaea. Indeed, investigators have recently shown for the first time that methanogens, which are Archaea microorganisms, constitute part of the flora responsible for certain cerebral abscesses and that they have a direct pathogenic role in cerebral abscesses. More specifically, the diagnosis of cerebral abscess includes several clinical and microbiological situations that are not all of the same therapeutic. Investigator propose to collect 20 abscesses. A collection of abscesses is performed systematically during the diagnosis for bacteriological analysis. There will be no further examination. The main objective of this clinical research project is to establish the repertoire of microorganisms responsible for brain abscesses; and as a secondary objective to define the different clinical entities forming the cerebral abscesses.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
Condition Brain Abscess
Intervention Other: Surgical puncture
Investigators propose to collect 20 abscesses. A collection of abscesses is performed systematically during the diagnostic for bacteriological analysis. There will be no further examination.
Study Groups/Cohorts Patients with an abscess
Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
Intervention: Other: Surgical puncture
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: July 11, 2019)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 30, 2023
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
  • Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

  • Pregnant or nursing woman.
  • Major patient under tutorship or curatorship.
  • Patient deprived of liberty or under a court order
  • Patient refusing to participate in the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Didier Raoult 04 13 73 20 51 didier.raoult@gmail.com
Contact: Alexandra Giuliani 04 91 38 28 70 promotion.interne@aphm.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04018742
Other Study ID Numbers 2018-59
2018-59 ( Registry Identifier: APHM )
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 Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date July 2019

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