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NCT03672487 · ClinicalTrials.gov registry record · Phase 3
Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age
A Phase 3 study of Chagas Disease, sponsored by Tulane University School of Public Health and Tropical Medicine.
- Active
- Registry status
- Phase 3
- Development phase
- 273
- Enrollment target
- 3
- Study locations
NCT03672487: Active Phase 3 study of Chagas Disease, sponsored by Tulane University School of Public Health and Tropical Medicine.
NCT03672487 is a Phase 3 study of Chagas Disease that is active but no longer recruiting, run by Tulane University School of Public Health and Tropical Medicine. The registered enrollment target is 273 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03672487, a Phase 3 study of Chagas Disease, is active but no longer recruiting, sponsored by Tulane University School of Public Health and Tropical Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 273 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG Benznidazole
Study Locations (3)
California
- University of California at San Diego - San Diego
Louisiana
- Tulane School of Public Health and Tropical Medicine - New Orleans
Other
- Institute for Clinical Effectiveness and Health Policy - Buenos Aires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2025-05-31 |
| Phase | Phase 3 |
What the registry record for NCT03672487 still lists
NCT03672487 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Chagas Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03672487 reports a single indexed study location in California, Louisiana, Other.
Frequently Asked Questions
What is clinical trial NCT03672487 about?
NCT03672487 is a clinical study titled "Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age". 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 seropositi...
What is the current status of trial NCT03672487?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 273 participants. The study started on 2019-06-01. Estimated completion is 2025-05-31.
What conditions does trial NCT03672487 study?
This clinical trial studies the following conditions: Chagas Disease.
What interventions are being tested in trial NCT03672487?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Benznidazole (DRUG).
Who is sponsoring clinical trial NCT03672487?
This trial is sponsored by Tulane University School of Public Health and Tropical Medicine, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03672487 being conducted?
This trial has 3 study locations across California, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chagas Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03672487's enrollment target sits among peer trials
273 1214th of 2000 higher than 787 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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