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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03672487

Acronym

BETTY

Enrollment

273

Registered

2018-09-14

Start date

2019-06-01

Completion date

2025-05-31

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Disease

Keywords

Congenital Transmission, Trypanosoma cruzi, Benznidazole

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.

Interventions

DRUGBenznidazole

Benznidazole tablet

DRUGPlacebo Oral Tablet

Sugar pill manufactured to mimic Benznidazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Placebo

Eligibility

Sex/Gender

FEMALE

Age

13 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg	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.
Frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg	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.

Secondary

Measure	Time frame	Description
The frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg immediately after BZN 30d/150mg	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.

Countries

Argentina, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026