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
em 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
/
3_ND
Problema de saúde:
1_doencas_transmissiveis
/
2_enfermedades_transmissibles
/
3_chagas_disease
/
3_neglected_diseases
Assunto principal:
Trypanosoma cruzi
/
Doença de Chagas
/
Nitroimidazóis
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
/
Pregnancy
País/Região como assunto:
America do sul
/
Argentina
Idioma:
En
Revista:
Reprod Health
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Argentina