Trials / Completed
CompletedNCT01547533
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease
Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.
Conditions
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2013-06-01
- Completion
- 2013-12-01
- First posted
- 2012-03-08
- Last updated
- 2015-03-18
Locations
1 site across 1 country: Argentina
Source: ClinicalTrials.gov record NCT01547533. Inclusion in this directory is not an endorsement.