Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease (LACTBENZ)

Hospital de Niños R. Gutierrez de Buenos Aires

Status: Completed

Conditions: Chagas Disease; Lactation

Study type: Observational

Funder types: Other

Identifiers

NCT01547533

LACT-BENZNIDAZOLE

Details and patient eligibility

About

The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.

Enrollment: 10 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 benznidazole 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

10 participants in 1 patient group

Lactating Women with Chagas disease

Description:

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