Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chagas Disease Lactation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No