Clinical Trials Logo
  1. Home
  2. Chagas Disease
  3. NCT03672487

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

Chagas Disease Clinical Trial

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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03672487
Study type Interventional
Source Tulane University
Contact Pierre Buekens, MD, PhD
Phone 5049888803
Email pbuekens@tulane.edu
Status Recruiting
Phase Phase 3
Start date June 1, 2019
Completion date May 31, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT01162967 - Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole Phase 2
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Active, not recruiting NCT04024163 - Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease Phase 3
Recruiting NCT05868005 - Delivering a Multi-disease Screening Tool to Migrant Populations N/A
Completed NCT03892213 - Pharmacokinetic Drug-Drug Interaction Study Phase 1
Recruiting NCT00875173 - Selenium Treatment and Chagasic Cardiopathy (STCC) Phase 3
Recruiting NCT03704181 - Colchicine for Patients With Chagas´ Disease( B1 Stage) Phase 2
Active, not recruiting NCT03378661 - BENDITA BEnznidazole New Doses Improved Treatment and Associations Phase 2
Completed NCT01927224 - Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients Phase 1
Completed NCT01006486 - Outcomes of an Anticoagulation Clinic in an University Hospital Phase 4
Completed NCT00123916 - BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease Phase 3
Completed NCT02516293 - Cardiac Rehabilitation in Chagas Heart Failure Phase 2/Phase 3
Completed NCT02517632 - Physical Exercise Program in Chronic Chagas Heart Disease Phase 3
Recruiting NCT02099903 - Renal Denervation in Patients With Heart Failure Secondary to Chagas Disease N/A
Completed NCT01874795 - Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure N/A
Completed NCT01006473 - Exercise Training in Chagas Cardiomyopathy Phase 4
Completed NCT02386358 - Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial Phase 3
Not yet recruiting NCT05477953 - An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
Completed NCT02346123 - Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy N/A
Recruiting NCT02295215 - Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction N/A