Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Nifurtimox concentration in breastmilk and in plasma
研究概览
简要总结
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.
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 nifurtimox 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
Nifurtimox concentration in breastmilk and in plasma
时间窗: at randomly selected, pre-specified, 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 transfer into breastmilk, if possible.
次要结局
- Incidence of adverse drug reactions in women treated with nifurtimox during lactation(throughout the 30 days of treatment)
研究者
Facundo Garcia-Bournissen
Associate Resesarcher
Hospital de Niños R. Gutierrez de Buenos Aires