Summary

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

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 not yet accepting patients
    San Diego California 92093 United States
  • Tulane School of Public Health and Tropical Medicine not yet accepting patients
    New Orleans Louisiana 70112 United States

Lead Scientist

  • Edmund Capparelli
    Senate Emeritus, Pediatrics. Authored (or co-authored) 162 research publications

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