ClinicalTrials.gg
Not yet recruitingNCT06242496Updated Feb 5, 2024

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

An observational study in Brain Abscess, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 0 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
0 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Abscess

Keywords

  • Brain abscess
  • Solid Organ Transplantation
  • Allogeneic hematopoietic stem cell transplantation
  • Immunosuppression
  • Opportunistic infections
03

In context

Opportunistic Infections

41 studies on the registry are indexed under Opportunistic Infections; 12 are open to participants now.

This study's planned enrollment of 200 is below the median of 504 across 20 observational studies indexed under Opportunistic Infections.

Browse Opportunistic Infections studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with brain abscesses after transplantation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Transplant recipient (i.e., solid organ transplant recipient or 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

Exclusion Criteria:

  • Opposition of the research
  • Patients under guardianship
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with brain abscesses after transplantation

    Other: Retrospective follow-up

Interventions

  • OtherRetrospective follow-up

    Data collection

06

What researchers measure

Primary outcomes

  1. Description of the current epidemiology of brain abscesses in transplant recipients

    Clinical and microbiological characteristics

    Time frame: 1 year after brain abscess diagnosis

Secondary outcomes

  1. 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

  2. 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

  3. 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

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

    in terms of antimicrobial therapy, immunomodulation, and neurosurgical management

    Time frame: 1 year after brain abscess diagnosis

  5. Assessment of the outcome of transplant recipients with brain abscesses

    i.e. one-year all cause mortality

    Time frame: 1 year after brain abscess diagnosis

  6. Identification of factors associated with patient survival in transplant recipients with brain abscesses

    Time frame: 1 year after brain abscess diagnosis

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2024; primary completion for Feb 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2024
First posted
Feb 5, 2024
StartEst.
Feb 1, 2024
Primary completionEst.
Feb 1, 2025
CompletionEst.
Feb 1, 2025
Last update
Feb 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06242496
Responsible party
Sponsor
First posted
Feb 5, 2024
Start date
Feb 1, 2024 (estimated)
Primary completion
Feb 1, 2025 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Feb 5, 2024

Study contacts

David Lebeaux, Pr
Contact
david.lebeaux@aphp.fr
+33156092969
Jérôme Lambert, Pr
Contact
jerome.lambert@u-paris.fr
+33142499742

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion