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Table 2 Exclusion criteria

From: Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial

Exclusion criteria
• 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.