Abstract
BackgroundRetrospective 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 designWe 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 registrationClinicalTrials.gov. Identifier: NCT03672487. Registered 14 September 2018
Highlights
Statement of the problem Chagas disease, or American trypanosomiasis, is caused by the protozoan parasite Trypanosoma cruzi
Storage of biological samples Consent/assent forms will include the authorization to participating study institutions to store blood specimens for up to 10 years for confirmatory studies related to the primary outcomes, and an opt-out option allowing the use of stored specimens for other confirmatory studies and for potential human genetic studies linked to mother-to-child transmission of T. cruzi
External quality assessment External quality assessment will be performed at the School of Public Health and Tropical Medicine (SPHTM) for serology and at the Instituto Nacional de Parasitología (INP) (Buenos Aires, Argentina) or a similar reference laboratory for conventional Polymerase Chain Reaction (PCR) and quantitative PCR (qPCR)
Summary
Statement of the problem Chagas disease, or American trypanosomiasis, is caused by the protozoan parasite Trypanosoma cruzi. Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. Studies and current recommendations on treatment to prevent congenital transmission Retrospective observational studies suggest that transmission of the Trypanosoma cruzi does not occur in treated women when pregnant later in life [7,8,9]. Two retrospective observational studies suggested that women treated at a young age do not transmit T. cruzi when pregnant later in life [7, 9]. Among the 222 children born to untreated women, 34 were infected with T. cruzi (15.3%), while no infection was found among the 132 children of previously treated women [7] Another small observational study found no congenital transmission among 15 women who became pregnant from one to 8 years after treatment [8]
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