NCT01744405

Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (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 nifurtimox into breastmilk of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at pre-specified times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by these women to nifurtimox. This study will help clarify safety of continuing breastfeeding while receiving treatment with nifurtimox for Chagas disease.

Conditions

• Chagas Disease
• Lactation

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2015-03-01
• First posted: 2012-12-06
• Last updated: 2015-03-18

Locations

1 site across 1 country: Argentina