|• 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.