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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chagas Disease, Lactation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lactating women with Chagas disease, not treated before Use of contraception Exclusion Criteria: History of allergy to benznidazole or its excipients Pregnancy Significant heart involvement (due to Chagas disease) Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lactating Women with Chagas disease<br>Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at randomly selected time points during the 30 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | throughout the 30 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chagas disease, lactation, breastmilk, postpartum period, infants, pediatric clinical pharmacology, developmental clinical pharmacology, parasitology, trypanosoma cruzi