Summary

for females ages 13 years and up (full criteria)
healthy people welcome
at San Diego, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Chagas Disease Congenital Transmission Trypanosoma cruzi Benznidazole Benzonidazole

Eligibility

You can join if…

Open to females ages 13 years and up

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

You CAN'T join if...

  • 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.

Locations

  • University of California at San Diego in progress, not accepting new patients
    San Diego California 92093 United States
  • Tulane School of Public Health and Tropical Medicine in progress, not accepting new patients
    New Orleans Louisiana 70112 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Tulane University School of Public Health and Tropical Medicine
ID
NCT03672487
Phase
Phase 3
Study Type
Interventional
Last Updated
September 13, 2018