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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Brain Abscess
• Intervention / Treatment: Other: Retrospective follow-up

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, Pr; Phone Number: +33142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: David Lebeaux, Pr; Phone Number: +33156092969; Email: david.lebeaux@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with brain abscesses after transplantation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with brain abscesses after transplantation	Other: Retrospective follow-up; Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the current epidemiology of brain abscesses in transplant recipients	Clinical and microbiological characteristics	1 year after brain abscess diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	in terms of antimicrobial therapy, immunomodulation, and neurosurgical management	1 year after brain abscess diagnosis
Assessment of the outcome of transplant recipients with brain abscesses	i.e. one-year all cause mortality	1 year after brain abscess diagnosis
Identification of factors associated with patient survival in transplant recipients with brain abscesses		1 year after brain abscess diagnosis

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Immunosuppression; Allogeneic hematopoietic stem cell transplantation; Brain abscess; Opportunistic infections; Solid Organ Transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Inflammation; Central Nervous System Infections; Suppuration; Abscess; Brain Abscess
• Other Study ID Numbers: APHP231787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No