Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
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 adul
| Condition(s) | Chagas Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion criteria (Subjects must meet ALL the inclusion requirements listed below to enter the study): * Signed informed consent form; * Between ≥18 and ≤60 years of age; * Weight ≥ 50 kg to ≤ 95 kg; * Confirmation of the diagnosis of T. cruzi infection by conventional serology (a minimum of two tests must be reactive); * Serial qualitative PCR (one blood sample divided in three DNA extractions, at least one of which must be positive); * Women of childbearing potential must have a negative pregnancy result at the time of inclusion, must not be breast-feeding, and must use a highly effective method of contraception during study treatment and until 30 days after the last dose of study treatment or demonstrate permanent sterilization; * Ability to comply with all exams and specific protocol |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Lead sponsor | Laboratorio Elea Phoenix S.A. |
| Locations | Buenos Aires, Argentina; Buenos Aires, Argentina; Buenos Aires, Argentina; Buenos Aires, Argentina; Corrientes, Argentina; Santiago del Estero, Argentina |
| Start date | 2021-07-28 |
| NCT ID | NCT04897516 |
| Official listing | https://clinicaltrials.gov/study/NCT04897516 |