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

Brain Abscess Clinical Trial

Official title:

Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242496
• Other study ID #: APHP231787
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: David Lebeaux, Pr
• Phone: +33156092969
• Email: david.lebeaux[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Brain Abscess

Intervention

Other:
• Retrospective follow-up
Data collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the current epidemiology of brain abscesses in transplant recipients	Clinical and microbiological characteristics	1 year after brain abscess diagnosis
Secondary	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
Secondary	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
Secondary	Identification of clinical predictors associated with fungal brain abscesses versus brain abscesses due to non-fungal organisms		1 year after brain abscess diagnosis
Secondary	Description of the current management of post-transplant brain abscesses in transplant recipients	in terms of antimicrobial therapy, immunomodulation, and neurosurgical management	1 year after brain abscess diagnosis
Secondary	Assessment of the outcome of transplant recipients with brain abscesses	i.e. one-year all cause mortality	1 year after brain abscess diagnosis
Secondary	Identification of factors associated with patient survival in transplant recipients with brain abscesses		1 year after brain abscess diagnosis