The host-microbiome in specialty patient populations

Not Applicable

Recruiting

• Conditions: Immunecompromised; End stage liver disease; Liver transplant; Leukemia; allogeneic stem cell transplant; Infection - Studies of infection and infectious agents; Cancer - Any cancer; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12623001105639
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-20
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 768

Inclusion Criteria

Adults greater than or equal to 18 years of age with acute leukemia undergoing induction/consolidation chemotherapy +/- planned for allogeneic stem cell transplant OR receiving cellular or immune based therapies OR waitlisted for liver transplant for end stage liver disease willing and able to provide informed consent or with a medical decision maker able to provide consent OR healthy controls

Exclusion Criteria

Participants will be excluded if (1) age less than 18 years; (2) either they or their medical treatment decision maker are unable or unwilling to provide written and informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First infection which is a composite of either cinicall or microbioloigcally defined infection<br>[Defined per the International Immunocompromised Host Society classification of microbiologically defined and clinically defined infections and fever of unknown focus per review of the electronic medical record Outcome will be asessed 6 monthly for up to 2 years post transplant or cancer immune therapy]

Secondary Outcome Measures

Name	Time	Method
First immune event which is a composite of either graft versus host disease (GVHD) or allograft rejection[The Mount Sinai Acute Graft Versus Host Disease International Consortium (MAGIC) criteria for acute graft versus host disease and Banff schema for grading liver allograft rejection per review of the electronic medical record Outcome will be asessed 6 monthly for up to 2 years post transplant or cancer immune therapy]