Clinical Trial: Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease

Brief 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.

Detailed Summary:
Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Current Primary Outcome: Benznidazole concentration in breastmilk and in plasma [ Time Frame: at randomly selected time points during the 30 days of treatment ]

Randomly obtained breastmilk samples will be obtained to both evaluate the breastmilk / plasma concentration ratio of the drug, and to develop a population pharmacokinetics model of drug trasfer into breastmilk, if possible.

Breastmilk concentrations will be used to calculate potential infant exposure through breastmilk to the medication (benznidazole) taken by the mother



Original Primary Outcome: Same as current

Current Secondary Outcome: incidence of adverse drug reactions in women treated with benznidazole during lactation [ Time Frame: throughout the 30 days of treatment ]

Women receiving treatment with benznidazole while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 60 days of the treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.


Original Secondary Outcome: Same as current

Information By: Hospital de Niños R. Gutierrez de Buenos Aires

Dates:
Date Received: March 1, 2012
Date Started: August 2011
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015