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Open Access 01-12-2022 | Hepatitis B | Study protocol

The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial

Authors: Ronnie Kasirye, Heather A. Hume, Evan M. Bloch, Irene Lubega, Dorothy Kyeyune, Ruchee Shrestha, Henry Ddungu, Hellen Wambongo Musana, Aggrey Dhabangi, Joseph Ouma, Priscilla Eroju, Telsa de Lange, Michael Tartakovsky, Jodie L. White, Ceasar Kakura, Mary Glenn Fowler, Philippa Musoke, Monica Nolan, M. Kate Grabowski, Lawrence H. Moulton, Susan L. Stramer, Denise Whitby, Peter A. Zimmerman, Deo Wabwire, Isaac Kajja, Jeffrey McCullough, Raymond Goodrich, Thomas C. Quinn, Robert Cortes, Paul M. Ness, Aaron A. R. Tobian

Published in: Trials | Issue 1/2022

Abstract

Background

Transfusion-transmitted infections (TTIs) are a global health challenge. One new approach to reduce TTIs is the use of pathogen reduction technology (PRT). In vitro, Mirasol PRT reduces the infectious load in whole blood (WB) by at least 99%. However, there are limited in vivo data on the safety and efficacy of Mirasol PRT. The objective of the Mirasol Evaluation of Reduction in Infections Trial (MERIT) is to investigate whether Mirasol PRT of WB can prevent seven targeted TTIs (malaria, bacteria, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, hepatitis E virus, and human herpesvirus 8).

Methods

MERIT is a randomized, double-blinded, controlled clinical trial. Recruitment started in November 2019 and is expected to end in 2024. Consenting participants who require transfusion as medically indicated at three hospitals in Kampala, Uganda, will be randomized to receive either Mirasol-treated WB (n = 1000) or standard WB (n = 1000). TTI testing will be performed on donor units and recipients (pre-transfusion and day 2, day 7, week 4, and week 10 after transfusion). The primary endpoint is the cumulative incidence of one or more targeted TTIs from the Mirasol-treated WB vs. standard WB in a previously negative recipient for the specific TTI that is also detected in the donor unit. Log-binomial regression models will be used to estimate the relative risk reduction of a TTI by 10 weeks associated with Mirasol PRT. The clinical effectiveness of Mirasol WB compared to standard WB products in recipients will also be evaluated.

Discussion

Screening infrastructure for TTIs in low-resource settings has gaps, even for major TTIs. PRT presents a fast, potentially cost-effective, and easy-to-use technology to improve blood safety. MERIT is the largest clinical trial designed to evaluate the use of Mirasol PRT for WB. In addition, this trial will provide data on TTIs in Uganda.

Trial registration

Mirasol Evaluation of Reduction in Infections Trial (MERIT) NCT03737669. Registered on 9 November 2018

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Title: The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial
Authors: Ronnie Kasirye
Heather A. Hume
Evan M. Bloch
Irene Lubega
Dorothy Kyeyune
Ruchee Shrestha
Henry Ddungu
Hellen Wambongo Musana
Aggrey Dhabangi
Joseph Ouma
Priscilla Eroju
Telsa de Lange
Michael Tartakovsky
Jodie L. White
Ceasar Kakura
Mary Glenn Fowler
Philippa Musoke
Monica Nolan
M. Kate Grabowski
Lawrence H. Moulton
Susan L. Stramer
Denise Whitby
Peter A. Zimmerman
Deo Wabwire
Isaac Kajja
Jeffrey McCullough
Raymond Goodrich
Thomas C. Quinn
Robert Cortes
Paul M. Ness
Aaron A. R. Tobian
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Hepatitis B
Malaria
Kaposi's Sarcoma-Associated Herpesvirus
Human Immunodeficiency Virus
Hepatitis C
Hepatitis E
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06137-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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