Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
- Conditions
- Chagas Disease
- Interventions
- Registration Number
- NCT04897516
- Lead Sponsor
- Laboratorio Elea Phoenix S.A.
- Brief 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.
- Detailed Description
Chagas disease is a vector-borne parasitic infection affecting an estimated 6 million people worldwide. Very few people have been able to access antiparasitic treatment for the disease, and about 20% of those who do initiate treatment are unable to complete it due to the long duration (2 months) and side effects associated with the current regimen. Benznidazole is one of only two drugs with proven efficacy against Trypanosoma cruzi, the parasite that causes the disease. An earlier Phase 2 clinical trial, BENDITA, indicated 89% of 30 patients treated with a shorter (2-week) regimen of benznidazole maintained sustained parasite clearance after 12 months of follow-up, with no discontinuations of treatment due to side effects. The current study will evaluate shorter treatment regimens with benznidazole in a Phase III clinical trial. NuestroBen will assess the efficacy and safety of 2-week and 4-week regimens of BZN (300 mg daily), compared to the standard treatment of BZN 300 mg daily for 8 weeks, in terms of reducing and eliminating the T. cruzi parasite in adults in the chronic phase of Chagas disease with the indeterminate form or mild cardiac progression. Efficacy will be measured through conversion from positive to negative parasitaemia according to the results of qualitative PCR tests from the end of treatment, and up to 12 months of follow-up from the end of treatment. Safety will be compared according to the frequency and severity of adverse events. Patients adherence to treatment in each study arm will also be described.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short regimen of benznidazole 2 weeks Short regimen of benznidazole Experimental: Short regimen of benznidazole Participants will receive an investigational treatment of benznidazole 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 2 weeks. Short regimen of benznidazole 4 weeks Short treatment with benznidazole Experimental: Short regimen of benznidazole Participants will receive an investigational treatment of benznidazole for 4 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. Standard treatment with benznidazole Standard treatment with benznidazole Active Comparator: Standard treatment with benznidazole Benznidazole, 300 mg divided into three daily doses (100 mg every 08 hours), orally for 8 weeks
- Primary Outcome Measures
Name Time Method Proportion of patients with sustained negativation of parasitemia according to the results of qualitative PCR tests From the end of treatment, and up to 12 months of follow-up from the end of treatment. Sustained parasitological response will be determined by negative serial qualitative PCR results (two negative PCR results from three DNA extractions from a sample) from the end of treatment with the elimination of sustained parasitaemia until the end of 12 months' follow-up from the end of treatment.
- Secondary Outcome Measures
Name Time Method Incidence of SAEs, Adverse Events of Special Interest (AESIs) and/or adverse events that cause treatment interruption From the end of treatment, and up to 12 months of follow-up from the end of treatment. Incidence of SAEs, Adverse Events of Special Interest (AESIs) and/or adverse events that cause treatment interruption
Proportion of patients with negative parasitemia at 1, 4, 6 and 8 months follow-up form the end of treatment 1, 4, 6 and 8 months from the end of treatment Proportion of patients with negative parasitemia at 1, 4, 6 and 8 months follow-up form the end of treatment
Descriptions of patients adherence to treatment in each study arm. 2, 4 and 8 weeks describing the number of completed treatment in patients vs uncompleted treatment in patients
Incidence and severity of adverse events From the end of treatment, and up to 12 months of follow-up from the end of treatment Incidence and severity of adverse events
Trial Locations
- Locations (6)
Fundación Huésped
🇦🇷Buenos Aires, Argentina
Hospital Donación Francisco Santojanni
🇦🇷Buenos Aires, Argentina
Centro de Chagas y Patología Regional, Hospital Independencia
🇦🇷Santiago Del Estero, Argentina
Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben"
🇦🇷Buenos Aires, Argentina
Hospital Francisco Javier Muñiz
🇦🇷Buenos Aires, Argentina
Instituto de Cardiología de Corrientes "Juana Francisca Cabral"
🇦🇷Corrientes, Argentina