TY - JOUR
T1 - The Mirasol Evaluation of Reduction in Infections Trial (MERIT)
T2 - study protocol for a randomized controlled clinical trial
AU - Kasirye, Ronnie
AU - Hume, Heather A.
AU - Bloch, Evan M.
AU - Lubega, Irene
AU - Kyeyune, Dorothy
AU - Shrestha, Ruchee
AU - Ddungu, Henry
AU - Musana, Hellen Wambongo
AU - Dhabangi, Aggrey
AU - Ouma, Joseph
AU - Eroju, Priscilla
AU - de Lange, Telsa
AU - Tartakovsky, Michael
AU - White, Jodie L.
AU - Kakura, Ceasar
AU - Fowler, Mary Glenn
AU - Musoke, Philippa
AU - Nolan, Monica
AU - Grabowski, M. Kate
AU - Moulton, Lawrence H.
AU - Stramer, Susan L.
AU - Whitby, Denise
AU - Zimmerman, Peter A.
AU - Wabwire, Deo
AU - Kajja, Isaac
AU - McCullough, Jeffrey
AU - Goodrich, Raymond
AU - Quinn, Thomas C.
AU - Cortes, Robert
AU - Ness, Paul M.
AU - Tobian, Aaron A.R.
N1 - Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Mirasol
KW - Pathogen reduction
KW - Randomized controlled trial
KW - Sub-Saharan Africa
KW - Transfusion-transmitted infections
KW - Uganda
UR - http://www.scopus.com/inward/record.url?scp=85127472102&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85127472102&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06137-8
DO - 10.1186/s13063-022-06137-8
M3 - Article
C2 - 35379302
AN - SCOPUS:85127472102
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 257
ER -