At a glance
ClinicalIndex Comparison Record- ✓Signed informed consent form
- ✓Age 18-60 years
- ✓Weight 50-95 kg
- ✓Confirmed T. cruzi infection by conventional serology (minimum 2 reactive tests)
- ✕Pregnant or intending to become pregnant during treatment and within 30 days of last dose
- ✕Signs/symptoms of established moderate-severe cardiac/digestive Chagas disease or ECG/echo findings not in inclusion criteria
- ✕History of cardiomyopathy, heart failure, or severe ventricular arrhythmia
- ✕History of digestive surgery related to Chagas disease or megacolon/mega-esophagus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04897516Phase 3RecruitingMonitorUpdated 31mo ago · Completion was 1mo agoPhase III Randomized,Multicenter Non-inferiority Study to Evaluate the Efficacy and Safety of Shorter Benznidazole Regimens Compared to the Standard Regimen to Treat Adult Patients With Chronic Chagas Disease
In Brief
A Phase 3 clinical trial evaluating Short regimen of benznidazole, Short treatment with benznidazole, and 1 other intervention for Chagas Disease. Currently recruiting, targeting 300 participants across 6 sites.
Signals
Detailed Summary
Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.
Study Details
Timeline
Interventions
Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 2 weeks.
Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 4 weeks.
Benznidazole, 300 mg divided into three daily doses (100 mg every 08 hours), orally for 8 weeks