Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): A non-inferiority randomized controlled trial study protocol

CAFFERATA, MARÍA L.; BELIZÁN, JOSE M.; CAPPARELLI, EDMUND V.; DUMONTEIL, ERIC; HERRERA, CLAUDIA; SHAFFER, JEFFREY G.; STELLA, CANDELA B.; CAFFERATA, MARÍA L.; BELIZÁN, JOSE M.; CAPPARELLI, EDMUND V.; DUMONTEIL, ERIC; HERRERA, CLAUDIA; SHAFFER, JEFFREY G.; STELLA, CANDELA B.; ALTHABE, FERNANDO; BERRUETA, MABEL; DANESI, EMMARIA; GULAYIN, PABLO E.; ROSSI, STEVEN; SOSA-ESTANI, SERGIO; BUEKENS, PIERRE; TOSCANI, MARÍA A.; ALTHABE, FERNANDO; BERGEL, EDUARDO; BERRUETA, MABEL; CIGANDA, ÁLVARO; DANESI, EMMARIA; GIBBONS, LUZ; GULAYIN, PABLO E.; MOMPER, JEREMIAH D.; ROSSI, STEVEN; SCHIJMAN, ALEJANDRO G.; SOSA-ESTANI, SERGIO; KLEIN, KAREN; BUEKENS, PIERRE; TOSCANI, MARÍA A.; BERGEL, EDUARDO; CIGANDA, ÁLVARO; GIBBONS, LUZ; MOMPER, JEREMIAH D.; SCHIJMAN, ALEJANDRO G.; KLEIN, KAREN

Reproductive Health

BioMed Central Ltd

Año: 2020 vol. 17

Background: Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300 mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300 mg course is not yet established. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed. Methods and design: We are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150 mg/day (30d/150 mg) vs. BZN 60d/300 mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum, and follow them up with the following specific aims: Specific aim 1: to measure the effect of BZN 30d/150 mg compared to 60d/300 mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately and 10 months after treatment. Specific aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption. Trial registration: ClinicalTrials.gov. Identifier: NCT03672487. Registered 14 September 2018