Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
ConditionChagas Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLaboratorio Elea Phoenix S.A.
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
Subject pregnant or intending to become pregnant during treatment and within 30 days of the last dose of study treatment;
Signs or symptoms of the established (moderate- severe) chronic cardiac and/or digestive form of Chagas disease, or any ECG/ echocardiographic findings not included at Inclusion criteria;
History of cardiomyopathy, heart failure, or severe ventricular arrhythmia;
History of digestive surgery potentially related to Chagas Disease or megacolon / mega-esophagus;
Trial design
Treatments tested in this trial
- Short regimen of benznidazole
- Short treatment with benznidazole
- Standard treatment with benznidazole
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Laboratorio Elea Phoenix S.A.
Lead sponsor
Drugs for Neglected Diseases
Collaborator
Source ClinicalTrials.gov