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

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

  2. Author Address

    MUJHU Research Collaboration, Kampala, Uganda., Department of Pediatrics, University of Montreal, Montr 233;al, QC, Canada., Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA., Uganda Blood Transfusion Services, Kampala, Uganda., Uganda Cancer Institute, Kampala, Uganda., Child Health and Development Centre, Makerere University College of Health Sciences, Kampala, Uganda., National Institute of Allergy and Infectious Diseases Office of Cyber Infrastructure and Computational Biology, Bethesda, MD, USA., Makerere University, Kampala, Uganda., Department of International Health, School of Public Health, Johns Hopkins University, Baltimore, MD, USA., Department of Scientific Affairs, American Red Cross, Gaithersburg, MD, USA., Leidos Biomedical Research, AIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA., The Center for Global Health & Diseases, Pathology Department, Case Western Reserve University, Cleveland, OH, USA., Department of Orthopaedics, Makerere University College of Health Sciences, Kampala, Uganda., College of Health Solutions, Arizona State University, Phoenix, AZ, USA., Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, USA., Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA., Terumo BCT, Lakewood, CO, USA., Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, MD, USA. atobian1@jhmi.edu., Department of Paediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda. atobian1@jhmi.edu.,
    1. Year: 2022
    2. Date: Apr 04
    3. Epub Date: 2022 04 04
  2. Journal: Trials
    1. 23
    2. 1
  4. Type of Article: Article
  5. Article Number: 257
  1. Abstract:

    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). 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. 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. Mirasol Evaluation of Reduction in Infections Trial (MERIT) NCT03737669 . Registered on 9 November 2018. © 2022. The Author(s).

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External Sources

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  2. DOI: 10.1186/s13063-022-06137-8
  3. PMID: 35379302
  4. PII : 10.1186/s13063-022-06137-8

Library Notes

  1. Fiscal Year: FY2021-2022
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