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

January 11, 2024 updated by: Tulane University School of Public Health and Tropical Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Institute for Clinical Effectiveness and Health Policy
        • Sub-Investigator:
          • Maria Luisa Cafferata, MD
        • Sub-Investigator:
          • Eduardo Bergel, MSc, PhD
        • Sub-Investigator:
          • Mabel Berrueta, MD
        • Sub-Investigator:
          • Jose Belizan, MD, PhD
        • Sub-Investigator:
          • Sergio Sosa-Estani, MD, PhD
        • Sub-Investigator:
          • Alejandro Schijman, DSc
        • Contact:
        • Sub-Investigator:
          • Fernando Althabe, MD, MSc
  • United States
    • California
      • San Diego, California, United States, 92093
        • Active, not recruiting
        • University of California at San Diego
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Active, not recruiting
        • Tulane School of Public Health and Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 60/300mg

The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax® 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). The investigators will purchase the drug at full cost.

Interventions: The standard 60d course will be 300 mg per day, which is similar to the dose used in the second phase of the BENEFIT trial. The drug will be administered orally in two doses per day: the standard course will be one 100mg and one 50mg tablet in the morning and in the evening for 60 days.
Drug: Benznidazole
Benznidazole tablet
Other Names:
  • Abarax
Experimental: 30/150mg

The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax® 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). ELEA laboratories will prepare the placebo oral tablets, which will be identical to the drug tablets in aspect and taste. The investigators will purchase the drug and placebo at full cost.

Interventions: The BZN short course low dose scheme will be 150 mg per day for 30 days. The drug will be administered orally in two doses per day: the short course treatment will start with the active drug and then placebo oral tablet; one 100 mg tablet and one placebo tablet in the morning and one 50 mg tablet and one placebo tablet in the evening for the first 30 days. The last 30 days will be two placebo tablets in the morning and the evening.
Drug: Benznidazole
Benznidazole tablet
Other Names:
  • Abarax
Drug: Placebo Oral Tablet
Sugar pill manufactured to mimic Benznidazole
Other Names:
  • Placebo (for Benznidazole)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg
Time Frame: 30 days for the 30d course arm, and 60 days for the 60d course arm
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.
30 days for the 30d course arm, and 60 days for the 60d course arm
The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg
Time Frame: 10 months from the end of the 60d treatment
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.
10 months from the end of the 60d treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg immediately after BZN 30d/150mg
Time Frame: 60 days after treatment initiation
The frequency of serious adverse events leading to treatment interruption will be 50% lower with BZN 30d/150mg than with BZN 60d/300mg.
60 days after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University School of Public Health and Tropical Medicine

Collaborators

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

Investigators

  • Principal Investigator: Pierre Buekens, MD, PhD, Tulane University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (Actual)

September 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD095587

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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