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

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ClinicalTrials.gov Identifier: NCT03672487
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Institute for Clinical Effectiveness and Health Policy
University of California, San Diego
Information provided by (Responsible Party):
Tulane University ( Tulane University School of Public Health and Tropical Medicine )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chagas Disease Drug: Benznidazole Drug: Placebo Oral Tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo
Primary Purpose: Treatment
Official Title: Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age: A Non-inferiority Randomized Controlled Trial
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease

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 Name: 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 Name: Abarax

Drug: Placebo Oral Tablet
Sugar pill manufactured to mimic Benznidazole
Other Name: Placebo (for Benznidazole)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women of childbearing age
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672487


Contacts
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Contact: Pierre Buekens, MD, PhD 5049888803 pbuekens@tulane.edu
Contact: Fernando Althabe, MD, MSc +54 11 4777-8767 falthabe@gmail.com

Locations
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United States, California
University of California at San Diego Active, not recruiting
San Diego, California, United States, 92093
United States, Louisiana
Tulane School of Public Health and Tropical Medicine Active, not recruiting
New Orleans, Louisiana, United States, 70112
Argentina
Institute for Clinical Effectiveness and Health Policy Recruiting
Buenos Aires, Argentina
Contact: Fernando Althabe, MD, MSc       falthabe@gmail.com   
Principal Investigator: Fernando Althabe, MD, MSc         
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         
Sponsors and Collaborators
Tulane University School of Public Health and Tropical Medicine
Institute for Clinical Effectiveness and Health Policy
University of California, San Diego
Investigators
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Principal Investigator: Pierre Buekens, MD, PhD Tulane University
  Study Documents (Full-Text)

Documents provided by Tulane University ( Tulane University School of Public Health and Tropical Medicine ):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tulane University School of Public Health and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03672487    
Other Study ID Numbers: R01HD095587
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tulane University ( Tulane University School of Public Health and Tropical Medicine ):
Congenital Transmission
Trypanosoma cruzi
Benznidazole
Additional relevant MeSH terms:
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Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Benzonidazole
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents