ew use of a drug named disulfiram for Chagas disease treatment
- Conditions
- Chagas diseaseC01.610
- Registration Number
- RBR-5n4htp
- Lead Sponsor
- Fundação Oswaldo Cruz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Adults; aged from 18 to 70 years; both sexes; diagnosis of chronic Chagas disease in the indeterminate form or cardiac form at stage A; two distinct serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence or chemiluminescence) positive for Chagas disease
Previous benznidazol (BZ) or dissulfiram (DF) treatment, contraindications or hypersensitivity; alcoholism; smoking; renal or hepatic impairment; gastrointestinal disorders; pulmonary, epileptic, haematological disorders; pregnancy or lactation; heart disease associated with moderate or severe orovalvar disease, ischemic, congenital or hypertensive heart disease; systemic diseases such as autoimmune disorders, cancer, other infectious diseases such as acquired immunodeficiency syndrome; use of 3 or more regular medications within 2 weeks before starting study treatment except for contraceptive (for women), omeprazol and sinvastatin; use of any eventual medication within 7 days before starting study treatment; use of any antifungal 60 days before starting study treatment; previous intervention studies one year before; severe cognitive impairments
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of toxicity (serious adverse events) caused by the combination of BZ and DF detected by clinical observation and blood tests in at least one third of the participants of a same study arm.
- Secondary Outcome Measures
Name Time Method Post-treatment negative T. cruzi PCR in more than 80% of the participants of the study arm.