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

Hospital de Niños R. Gutierrez de Buenos Aires

Status: Completed

Conditions: Chagas Disease; Lactation

Study type: Observational

Funder types: Other

Identifiers

NCT01744405

LACT-NIFURTIMOX

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Lactating Women with Chagas disease

Description:

Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, and who are also lactating