Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age (BETTY)
Chagas Disease
About this trial
This is an interventional treatment trial for Chagas Disease focused on measuring Congenital Transmission, Trypanosoma cruzi, Benznidazole
Eligibility Criteria
Inclusion Criteria:
- Written informed consent from the mother.
- T. cruzi seropositivity confirmed by at least two positive tests.
- Live birth.
Exclusion Criteria:
- Women residing outside of the provinces of Chaco, Santiago del Estero, or Tucumán.
- Previous trypanocide treatment (BZN or nifurtimox).
- Female sterilization; no intention to use modern contraception methods during treatment.
- Positive pregnancy test.
- History of severe alcohol abuse within two years; renal insufficiency.
Sites / Locations
- University of California at San Diego
- Tulane School of Public Health and Tropical Medicine
- Institute for Clinical Effectiveness and Health PolicyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
60/300mg
30/150mg
The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax® 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). The investigators will purchase the drug at full cost. Interventions: The standard 60d course will be 300 mg per day, which is similar to the dose used in the second phase of the BENEFIT trial. The drug will be administered orally in two doses per day: the standard course will be one 100mg and one 50mg tablet in the morning and in the evening for 60 days.
The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax® 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). ELEA laboratories will prepare the placebo oral tablets, which will be identical to the drug tablets in aspect and taste. The investigators will purchase the drug and placebo at full cost. Interventions: The BZN short course low dose scheme will be 150 mg per day for 30 days. The drug will be administered orally in two doses per day: the short course treatment will start with the active drug and then placebo oral tablet; one 100 mg tablet and one placebo tablet in the morning and one 50 mg tablet and one placebo tablet in the evening for the first 30 days. The last 30 days will be two placebo tablets in the morning and the evening.