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NCT Number: NCT03672487

Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age

The investigators are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short 30-day treatment with BZN 150mg/day (30d/150mg) vs. a 60-day treatment with BZN 300 mg/day (60d/300mg). The investigators will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at six months postpartum, and follow them up with the following specific aims:

Specific Aim 1: To measure the effect of BZN 30d/150mg compared to 60d/300mg preconceptional treatment on parasitic load measured by the frequency of positive PCR (primary outcome) and by real-time quantitative PCR (qPCR), immediately (Specific Aim 1a) and 10 months (Specific Aim 1b) after treatment.

Hypothesis 1a: The frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg will be non-inferior (Non Inferiority [NI] margin for PCR: 10% absolute difference) to BZN 60d/300mg.

Hypothesis 1b: The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg will be non-inferior (NI margin for PCR: 9% absolute difference) to BZN 60d/300mg.

Specific Aim 2: To measure the frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg.

Hypothesis 2: The frequency of serious adverse events leading to treatment interruption will be 50% lower with BZN 30d/150mg than with BZN 60d/300mg.

A 24-month recruitment period is planned in four hospitals with 23,436 deliveries in 2015 and frequencies of T. cruzi seropositive women varying from 1.5% to 4.8%. The investigators are planning to enroll 600 T. cruzi seropositive women.

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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

13 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent from the mother.
  • T. cruzi seropositivity confirmed by at least two positive tests.
  • Live birth.

Exclusion criteria

  • Women residing outside of the provinces of Chaco, Santiago del Estero, or Tucumán.
  • Previous trypanocide treatment (BZN or nifurtimox).
  • Female sterilization; no intention to use modern contraception methods during treatment.
  • Positive pregnancy test.
  • History of severe alcohol abuse within two years; renal insufficiency.

Treatment and study plan

Benznidazole

Drug

Benznidazole tablet

Other names: Abarax

Placebo oral tablet

Drug

Sugar pill manufactured to mimic Benznidazole

Other names: Placebo (for Benznidazole)

Primary outcomes

  1. Global PCR (Conventional PCR and Real-time Quantitative PCR) Immediately After the End of Treatment.

    Time frame: Immediately after the end of treatment: 30 days for the 30-day arm, and 60 days for the 60-day arm.

    Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive.

  2. Global PCR (Conventional PCR and Real-time Quantitative PCR) at 10 Months After the End of the 60-day Treatment Period.

    Time frame: 10 months after the end of the 60-day treatment period.

    Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive.

Secondary outcomes

  1. Serious Adverse Events and/or Any Adverse Event Leading to Treatment Discontinuation.

    Time frame: Randomization until last visit (10 months after the end of treatment or early termination).

  2. Median Parasitic Load by qPCR Immediately After the End of Treatment in Detectable Samples.

    Time frame: Immediately after the end of treatment.

    Parasitic equivalents/mL.

  3. Median Parasitic Load by qPCR at 10 Months From the End of the 60-day Treatment Period in Detectable Samples

    Time frame: 10 months from the end of the 60-day treatment period.

    Parasitic equivalents/mL.

Sponsors and collaborators

Lead sponsor

Tulane University School of Public Health and Tropical Medicine

Other

Collaborators

  • Institute for Clinical Effectiveness and Health Policy
  • University of California, San Diego

Registry information

Official study title

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

Acronym: BETTY

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Sep 14, 2018
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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