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

Chagas Disease Clinical Trial

— BETTY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03672487
• Other study ID #: R01HD095587
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2024
• Source: Tulane University
• Contact: Pierre Buekens, MD, PhD
• Phone: 5049888803
• Email: pbuekens[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Drug:
• Benznidazole
Benznidazole tablet
• Placebo Oral Tablet
Sugar pill manufactured to mimic Benznidazole

Locations

Country	Name	City	State
Argentina	Institute for Clinical Effectiveness and Health Policy	Buenos Aires
United States	Tulane School of Public Health and Tropical Medicine	New Orleans	Louisiana
United States	University of California at San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University School of Public Health and Tropical Medicine	Institute for Clinical Effectiveness and Health Policy, University of California, San Diego

Countries where clinical trial is conducted

United States,  Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg	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
Primary	The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg	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	The frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg immediately after BZN 30d/150mg	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