Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study (BAT-STUDY)

NCT06242496 | Unknown

• 1 other identifier: APHP231787
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brain Abscess

Keywords

Brain abscess; Solid Organ Transplantation; Allogeneic hematopoietic stem cell transplantation; Immunosuppression; Opportunistic infections

Outcome Measures

Primary Outcomes (1)

• Description of the current epidemiology of brain abscesses in transplant recipients

  Clinical and microbiological characteristics

  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

  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)

  1 year after brain abscess diagnosis

• Identification of clinical predictors associated with fungal brain abscesses versus brain abscesses due to non-fungal organisms

  1 year after brain abscess diagnosis

• Description of the current management of post-transplant brain abscesses in transplant recipients

  1 year after brain abscess diagnosis

• Assessment of the outcome of transplant recipients with brain abscesses

  1 year after brain abscess diagnosis

Study Arms (1)

Patients with brain abscesses after transplantation

Other: Retrospective follow-up

Interventions

Retrospective follow-up OTHER

Data collection

Patients with brain abscesses after transplantation

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with brain abscesses after transplantation

You may qualify if:

• 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

You may not qualify if:

• Opposition of the research
• Patients under guardianship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Brain Abscess; Opportunistic Infections

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Abscess; Suppuration; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

David Lebeaux, Pr

CONTACT

+33156092969; david.lebeaux@aphp.fr

Jérôme Lambert, Pr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-01