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.
Study Type
OBSERVATIONAL
Enrollment
10
Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Buenos Aires, Buenos Aires, Argentina
Benznidazole concentration in breastmilk and in plasma
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
Time frame: at randomly selected time points during the 30 days of treatment
incidence of adverse drug reactions in women treated with benznidazole during lactation
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.
Time frame: throughout the 30 days of treatment
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