Exclusion criteria | |
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• Having previously received treatment with benznidazole or nifurtimox (either completely or incompletely) | |
• Signs and/or symptoms of severe cardiac form of Chagas disease (as confirmed by local national guidelines) | |
• Impossibility to complete the specified protocol follow-up visits | |
• Acute or chronic health problems that, in the opinion of the principal investigator, may interfere with the evaluation of the efficacy and/or safety related to the drug (for example, acute infections, human immunodeficiency virus infection, liver or kidney disease) | |
• History of alcohol abuse | |
• Known hypersensitivity to metronidazole drugs | |
• Concomitant use or history of use of allopurinol, antimicrobial, antiparasitic, or antifungal agents | |
• Having laboratory parameters outside the range of normal or that are considered clinically relevant by the responsible physician: ◦ Total leukocyte count must be within the normal range, with an acceptable range of ± 5%. ◦ Total platelet count must be within the normal range up to 550,000/mm3 or 550 × 109/L. ◦ Total bilirubin must be within the normal range. ◦ Transaminase levels must be within the normal range, with an acceptable range of 25% above the upper limit of normal (ULN). ◦ Total creatinine level must be within the normal range, with an acceptable variation of 10% above the ULN. ◦ Alkaline phosphatase level must be within the normal range up to < 2.5× ULN. ◦ Gamma glutamyl transferase level must be within the normal range up to 2× ULN. ◦ Fasting glucose must be within the normal range. |