Condition or disease | Intervention/treatment |
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Brain Abscess | Other: Surgical puncture |
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 |
Group/Cohort | Intervention/treatment |
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Patients with an abscess
Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Didier Raoult | 04 13 73 20 51 | didier.raoult@gmail.com | |
Contact: Alexandra Giuliani | 04 91 38 28 70 | promotion.interne@aphm.fr |
Tracking Information | |||||||||
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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 |
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.
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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 |
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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.
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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
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04018742 | ||||||||
Other Study ID Numbers | 2018-59 2018-59 ( Registry Identifier: APHM ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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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 |