Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease (LACTNFX)
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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Buenos Aires、阿根廷、1425
- Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Lactating women with Chagas disease, not treated before
- Use of contraception
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
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Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, and who are also lactating
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Nifurtimox concentration in breastmilk and in plasma
大体时间：at randomly selected, pre-specified, time points during the 30 days of treatment
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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.
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at randomly selected, pre-specified, time points during the 30 days of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of adverse drug reactions in women treated with nifurtimox during lactation
大体时间：throughout the 30 days of treatment
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Women receiving treatment with nifurtimox while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 30 days of treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.
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throughout the 30 days of treatment
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合作者和调查者
调查人员
- 首席研究员：Facundo Garcia Bournissen, MD PhD、Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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