Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Nifurtimox concentration in breastmilk and in plasma
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Nifurtimox concentration in breastmilk and in plasma
Time Frame: 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.
Secondary Outcomes
- Incidence of adverse drug reactions in women treated with nifurtimox during lactation(throughout the 30 days of treatment)
Investigators
Facundo Garcia-Bournissen
Associate Resesarcher
Hospital de Niños R. Gutierrez de Buenos Aires