Clinical trial NCT06242496: Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study (BAT-STUDY)
Official title: Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Abscess
Keywords: Brain abscess
Solid Organ Transplantation
Allogeneic hematopoietic stem cell transplantation
Immunosuppression
Opportunistic infections
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain abscesses after transplantation

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Opposition of the research
* Patients under guardianship

Primary outcomes:
measure: Description of the current epidemiology of brain abscesses in transplant recipients
timeFrame: 1 year after brain abscess diagnosis
Secondary outcomes:
measure: Comparison of the clinical and microbiological characteristics of brain abscesses between solid organ transplant recipients and allogeneic hematopoietic stem cell transplant recipients
timeFrame: 1 year after brain abscess diagnosis
measure: Compare the clinical and microbiological characteristics of brain abscesses occurring early after transplantation (<M6) with those of brain abscesses occurring later after transplant (> M6)
timeFrame: 1 year after brain abscess diagnosis
measure: Identification of clinical predictors associated with fungal brain abscesses versus brain abscesses due to non-fungal organisms
timeFrame: 1 year after brain abscess diagnosis
measure: Description of the current management of post-transplant brain abscesses in transplant recipients
timeFrame: 1 year after brain abscess diagnosis
measure: Assessment of the outcome of transplant recipients with brain abscesses
timeFrame: 1 year after brain abscess diagnosis
measure: Identification of factors associated with patient survival in transplant recipients with brain abscesses
timeFrame: 1 year after brain abscess diagnosis
Other outcomes:
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