Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a n
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Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a noninferiority randomized controlled trial study protocol María L. Cafferata1,2* , María A. Toscani1, Fernando Althabe3, Jose M. Belizán1, Eduardo Bergel1, Mabel Berrueta1, Edmund V. Capparelli4,5, Álvaro Ciganda1,2, Emmaria Danesi6, Eric Dumonteil7, Luz Gibbons1, Pablo E. Gulayin1, Claudia Herrera7, Jeremiah D. Momper4, Steven Rossi5, Jeffrey G. Shaffer7, Alejandro G. Schijman8, Sergio Sosa-Estani9,10, Candela B. Stella1, Karen Klein1 and Pierre Buekens7
Abstract 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 (Continued on next page)
* Correspondence: [email protected] 1 Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina 2 Unidad de Investigación Clínica y Epidemiológica Montevideo (UNICEM), Montevideo, Uruguay Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third p
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