Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.
Reprod Health
; 17(1): 128, 2020 Aug 24.
Article
en En
| MEDLINE
| ID: mdl-32831069
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 ANDDESIGN:
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 specificaims:
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.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Trypanosoma cruzi
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Enfermedad de Chagas
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Nitroimidazoles
Tipo de estudio:
Diagnostic_studies
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Guideline
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
País/Región como asunto:
America do sul
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Argentina
Idioma:
En
Revista:
Reprod Health
Año:
2020
Tipo del documento:
Article