Brain AbscessNCT04018742
MICROBIOLOGY OF CEREBRAL ABSCESSES
An observational study of Brain Abscess, run by Assistance Publique Hopitaux De Marseille.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Abscess
- What is being tested?
- Surgical puncture
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: MICROBIOLOGY OF CEREBRAL ABSCESSES (ABCES)
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.
Read the 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.
- Conditions
- Brain Abscess
- Being tested
- Surgical puncture
- Medical subject headings
- Brain Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical punctureOther
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 group | Role | What they receive |
|---|---|---|
| Patients with an abscess | Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care. Receives: Other: Surgical puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matrix Assisted Laser Desorption Ionisation - Time of Flight
A matrix and a sample are deposited on a target. Pulsed lasers are fast charging.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AbscessStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018742
- Sponsor's protocol ID
- 2018-59
- Other IDs
- 2018-59
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICROBIOLOGY OF CEREBRAL ABSCESSES (ABCES)
- ClinicalTrials.gov ID
- NCT04018742
- Acronym / sponsor ID
- 2018-59
- Conditions
- Brain Abscess
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an abscess | – | Other: Surgical puncturePatient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with a cerebral abscess at admission; and to benefit from an abscess puncture as part of routine care.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical punctureInvestigators propose to collect 20 abscesses. A collection of abscesses is performed systematically during the diagnostic for bacteriological analysis. There will be no further examination. | Other | Patients with an abscess |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Related trials for Brain Abscess
Not yet recruiting
Circulating Cell-Free DNA for Brain Abscess Diagnosis: A Pilot Study
Brain Abscess
RecruitingObservational study
Study of a Cohort of Non-HIV Immunocompromised Patients With Toxoplasmosis at the Strasbourg University Hospital
Cerebral Toxoplasmosis
RecruitingObservational study
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Intracranial Hemorrhage, Ventriculitis
RecruitingObservational study
Cognitive Function and Fatigue After Brain Abscess
Brain Abscess, Fatigue
RecruitingPhase 4
Partial Oral Antibiotic Treatment for Bacterial Brain Abscess
Brain Abscess, Cerebral Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Abscess, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Didier Raoult (04 13 73 20 51, didier.raoult@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matrix Assisted Laser Desorption Ionisation - Time of Flight (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.