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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04018742
Other study ID # 2018-59
Secondary ID 2018-59
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 30, 2023

Study information

Verified date July 2019
Source Assistance Publique Hopitaux De Marseille
Contact Didier Raoult
Phone 04 13 73 20 51
Email didier.raoult@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date October 30, 2023
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type Measure Description Time frame Safety issue
Primary Matrix Assisted Laser Desorption Ionisation - Time of Flight A matrix and a sample are deposited on a target. Pulsed lasers are fast charging. 1 day
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