Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Benznidazole concentration in breastmilk and in plasma
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Lactating women with Chagas disease, not treated before
- •Use of contraception
排除标准
- •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
结局指标
主要结局
Benznidazole concentration in breastmilk and in plasma
时间窗: 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
次要结局
- incidence of adverse drug reactions in women treated with benznidazole during lactation(throughout the 30 days of treatment)
研究者
Facundo Garcia-Bournissen
Associate Researcher
Hospital de Niños R. Gutierrez de Buenos Aires