Brain AbscessNCT06242496
Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study (BAT-STUDY)
An observational study of Brain Abscess, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Allotransplantation is the process of transferring organ(s), tissue(s) or cell(s) from a healthy donor to a recipient. The two main applications of allotransplantation are solid organ transplantation and allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Brain Abscess
- What is being tested?
- Retrospective follow-up
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Feb 2025
- 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 0 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with brain abscesses after transplantation
Who may be able to join
- Transplant recipient (i.e., solid organ transplant recipient or allogeneic hematopoietic stem cell transplant recipient)
- Radiological evidence of brain abscess(es) after transplantation
- Brain abscess(es) classified as either proven, probable or possible (see definitions below)Diagnosis of brain abscess made between January 2010 and December 2021
Who cannot join
- Opposition of the research
- Patients under guardianship
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study
Allotransplantation is the process of transferring organ(s), tissue(s) or cell(s) from a healthy donor to a recipient. The two main applications of allotransplantation are solid organ transplantation and allogeneic hematopoietic stem cell transplantation. For several reasons, including the need to use immunosuppressive drugs after transplantation, recipients of allografts carry a high risk of infectious complications.
Central nervous system infections are dreadful complications of transplantation, which can be divided into brain abscesses, meningitis, and encephalitis. In particular, brain abscesses pose major diagnostic and therapeutic challenges to transplant physicians, and are frequently fatal in transplant recipients. As compared with immunocompetent patients, transplant recipients and other immunocompromised patients have an increased risk of brain abscesses due to opportunistic pathogens, including fungi, parasites, bacteria, and mycobacteria.
Read more
Determining the epidemiology of brain abscesses is critical to guide transplant teams regarding the diagnosis and management of brain abscesses in transplant recipients.
Because the incidence of brain abscesses is low after transplantation, transplant teams often have limited clinical experience in the management of these infections. Similarly, most publications focusing on post-transplant brain abscesses are either case reports, small case series, or review articles.
We therefore aim to conduct a multicentre retrospective study on the epidemiology, the characteristics, and the outcome of brain abscesses in transplant recipients in the era of new diagnostic tools and progress in prophylaxis.
- Conditions
- Brain Abscess
- Being tested
- Retrospective follow-up
- Keywords
- Brain abscess, Solid Organ Transplantation, Allogeneic hematopoietic stem cell transplantation, Immunosuppression, Opportunistic infections
- Medical subject headings
- Brain Abscess, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective follow-upOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| Patients with brain abscesses after transplantation | Not described Receives: Other: Retrospective follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the current epidemiology of brain abscesses in transplant recipients
Clinical and microbiological characteristics
Measured: 1 year after brain abscess diagnosis
Secondary outcomes (6)
Comparison of the clinical and microbiological characteristics of brain abscesses between solid organ transplant recipients and allogeneic hematopoietic stem cell transplant recipients
Measured: 1 year after brain abscess diagnosis
Compare the clinical and microbiological characteristics of brain abscesses occurring early after transplantation (<M6) with those of brain abscesses occurring later after transplant (> M6)
Measured: 1 year after brain abscess diagnosis
Identification of clinical predictors associated with fungal brain abscesses versus brain abscesses due to non-fungal organisms
Measured: 1 year after brain abscess diagnosis
Description of the current management of post-transplant brain abscesses in transplant recipients
in terms of antimicrobial therapy, immunomodulation, and neurosurgical management
Measured: 1 year after brain abscess diagnosis
Assessment of the outcome of transplant recipients with brain abscesses
i.e. one-year all cause mortality
Measured: 1 year after brain abscess diagnosis
Identification of factors associated with patient survival in transplant recipients with brain abscesses
Measured: 1 year after brain abscess diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (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 - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242496
- Sponsor's protocol ID
- APHP231787
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study
- ClinicalTrials.gov ID
- NCT06242496
- Acronym / sponsor ID
- APHP231787
- Conditions
- Brain Abscess
- Keywords
- Brain abscess, Solid Organ Transplantation, Allogeneic hematopoietic stem cell transplantation, Immunosuppression, Opportunistic infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 5 Feb 2024 (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.
Allotransplantation is the process of transferring organ(s), tissue(s) or cell(s) from a healthy donor to a recipient. The two main applications of allotransplantation are solid organ transplantation and allogeneic hematopoietic stem cell transplantation. For several reasons, including the need to use immunosuppressive drugs after transplantation, recipients of allografts carry a high risk of infectious complications.
Central nervous system infections are dreadful complications of transplantation, which can be divided into brain abscesses, meningitis, and encephalitis. In particular, brain abscesses pose major diagnostic and therapeutic challenges to transplant physicians, and are frequently fatal in transplant recipients. As compared with immunocompetent patients, transplant recipients and other immunocompromised patients have an increased risk of brain abscesses due to opportunistic pathogens, including fungi, parasites, bacteria, and mycobacteria.
Determining the epidemiology of brain abscesses is critical to guide transplant teams regarding the diagnosis and management of brain abscesses in transplant recipients.
Because the incidence of brain abscesses is low after transplantation, transplant teams often have limited clinical experience in the management of these infections. Similarly, most publications focusing on post-transplant brain abscesses are either case reports, small case series, or review articles.
We therefore aim to conduct a multicentre retrospective study on the epidemiology, the characteristics, and the outcome of brain abscesses in transplant recipients in the era of new diagnostic tools and progress in prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with brain abscesses after transplantation | – | Other: Retrospective follow-up |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with brain abscesses after transplantation
Key inclusion criteria (3 listed)
- Transplant recipient (i.e., solid organ transplant recipient or allogeneic hematopoietic stem cell transplant recipient)
- Radiological evidence of brain abscess(es) after transplantation
- Brain abscess(es) classified as either proven, probable or possible (see definitions below)Diagnosis of brain abscess made between January 2010 and December 2021
Key exclusion criteria (2 listed)
- Opposition of the research
- Patients under guardianship
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 |
|---|---|---|
| Retrospective follow-upData collection | Other | Patients with brain abscesses after transplantation |
Primary outcome
Description of the current epidemiology of brain abscesses in transplant recipients
Time frame: 1 year after brain abscess diagnosis
Clinical and microbiological characteristics
6 secondary outcomes
Comparison of the clinical and microbiological characteristics of brain abscesses between solid organ transplant recipients and allogeneic hematopoietic stem cell transplant recipients
Time frame: 1 year after brain abscess diagnosis
Compare the clinical and microbiological characteristics of brain abscesses occurring early after transplantation (<M6) with those of brain abscesses occurring later after transplant (> M6)
Time frame: 1 year after brain abscess diagnosis
Identification of clinical predictors associated with fungal brain abscesses versus brain abscesses due to non-fungal organisms
Time frame: 1 year after brain abscess diagnosis
Description of the current management of post-transplant brain abscesses in transplant recipients
Time frame: 1 year after brain abscess diagnosis
Assessment of the outcome of transplant recipients with brain abscesses
Time frame: 1 year after brain abscess diagnosis
Identification of factors associated with patient survival in transplant recipients with brain abscesses
Time frame: 1 year after brain abscess diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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 - Hôpitaux de Paris.
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 3 inclusion and 2 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 5 Feb 2024. 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 David Lebeaux, Pr (+33156092969, david.lebeaux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the current epidemiology of brain abscesses in transplant recipients (time frame: 1 year after brain abscess diagnosis). 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 5 Feb 2024.