Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT01489228
Eligibility Criteria:
Screening Criteria:
* Age \>18 to \< 50 years
* Weight \> 40 kg
* Diagnosis of T. cruzi infection by conventional serology (a minimum of two out of three positive tests \[enzyme linked immunosorbent assay (ELISA), indirect immunofluorescence (IIF), or hemagglutination inhibition (HAI)\])
* Signed, written informed consent form
* No signs and/or symptoms of the chronic cardiac and/or digestive form of CD
* No acute or chronic health conditions that may interfere with the efficacy and/or safety evaluation of the study drug
* No formal contraindication to BZN and E1224
* No known history of hypersensitivity, allergic, or serious adverse reactions to the study drugs
* No history of CD treatment with BZN or NFX at any time in the past
* No history of systemic treatment with itraconazole, ketoconazole, posaconazole, isavuconazole, or allopurinol in the past
Inclusion Criteria:
* Confirmed diagnosis of T. cruzi infection by serial qualitative PCR AND Conventional serology
* Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, and consistently use and/or have partner consistently use an adequate contraceptive method
* Normal ECG at screening
Exclusion Criteria:
* Abnormal laboratory test values at screening for the following parameters: total White Blood Cells (WBC) count, platelet count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, or creatinine; or gamma-glutamyl transferase (GGT)
* History of alcohol abuse or any other drug addiction (as specified in the Study Manual of Operations)
* Any condition that prevents the patient from taking oral medication
* Any concomitant use of antimicrobial or antiparasitic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01489228
Study Brief:
Protocol Section:
NCT01489228