Clinical Trial: Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease
Brief 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.
Detailed Summary:
Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Current Primary Outcome: Nifurtimox concentration in breastmilk and in plasma [ Time Frame: at randomly selected, pre-specified, time points during the 30 days of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidence of adverse drug reactions in women treated with nifurtimox during lactation [ Time Frame: throughout the 30 days of treatment ]
Original Secondary Outcome: Same as current
Information By: Hospital de Niños R. Gutierrez de Buenos Aires
Dates:
Date Received: December 5, 2012
Date Started: December 2012
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015