Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age
Status:
Recruiting
Trial end date:
2023-05-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Tulane University School of Public Health and Tropical Medicine
Collaborators:
Institute for Clinical Effectiveness and Health Policy University of California, San Diego