Evidence map›Paper›PMID 32831069›Full record

ArticleReproductive health2020

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

María L Cafferata, María A Toscani, Fernando Althabe, Jose M Belizán, Eduardo Bergel, Mabel Berrueta, Edmund V Capparelli, Álvaro Ciganda, Emmaria Danesi, Eric Dumonteil and 11 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Reproductive health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03672487 (Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03672487 phase3completednot on this map

Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age: A Non-inferiority Randomized Controlled Trial

TypeinterventionalSponsorTulane University School of Public Health and Tropical MedicineRan2019 to 2025Enrolled87ConditionsChagas DiseaseArmsBenznidazole, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  14. Intra-hostMicrobiology spectrum · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

María L CafferataInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina. mcafferata@iecs.org.ar.ORCID http://orcid.org/0000-0002-9928-5522
María A ToscaniInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Fernando AlthabeMaternal and Perinatal Health. UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research (SRH), World Health Organization, Geneva, Switzerland.
Jose M BelizánInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Eduardo BergelInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Mabel BerruetaInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Edmund V CapparelliSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego (UCSD), San Diego, USA.
Álvaro CigandaInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Emmaria DanesiCentro Nacional de Diagnóstico e Investigación en Endemoepidemias (CeNDIE) ANLIS Dr. C. G. Malbrán, Buenos Aires, Argentina.
Eric DumonteilSchool of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.
Luz GibbonsInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Pablo E GulayinInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Claudia HerreraSchool of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.
Jeremiah D MomperSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego (UCSD), San Diego, USA.
Steven RossiSchools of Medicine, University of California, San Diego (UCSD), San Diego, USA.
Jeffrey G ShafferSchool of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.
Alejandro G SchijmanLaboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh), Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor Torres" (INGEBI), Buenos Aires, Argentina.
Sergio Sosa-EstaniDrugs for Neglected Diseases initiative - Latin America (DNDi), Rio de Janeiro, Brazil.
Candela B StellaInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Karen KleinInstituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.
Pierre BuekensSchool of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.

Funding

Short-course Benznidazole Treatment to Reduce Trypanosoma cruzi Parasitic Load in Women of Reproductive Age: A Non-inferiorityRandomized Controlled TrialR01HD095857 · NICHD · TULANE UNIVERSITY OF LOUISIANA · PI BUEKENS, PIERRE, CAFFERATA, MARÍA LUISA · 2018 to 2022
$2.6M
Eunice Kennedy Shriver National Institute of Child Health and Human Development (US) R01 HD 095857NICHD NIH HHS R01 HD095857World Health Organization 001
6 · The paper itself

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.

Indexed as

ArgentinaChagas DiseaseFemaleHumansNitroimidazolesParasite LoadPostpartum PeriodPregnancyRandomized Controlled Trials as TopicReal-Time Polymerase Chain ReactionRetrospective StudiesTrypanosoma cruzibenzonidazoleNitroimidazolesBenznidazoleChagas diseasePreconception careRandomized controlled trialTrypanosoma cruzi

Identifiers

PMID32831069
PMCPMC7446054

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.