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

Completed

• Conditions: Chagas Disease; Lactation

• Registration Number: NCT01547533
• Lead Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Benznidazole concentration in breastmilk and in plasma	at randomly selected 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 trasfer into breastmilk, if possible.; Breastmilk concentrations will be used to calculate potential infant exposure through breastmilk to the medication (benznidazole) taken by the mother

Secondary Outcome Measures

Name	Time	Method
incidence of adverse drug reactions in women treated with benznidazole during lactation	throughout the 30 days of treatment	Women receiving treatment with benznidazole while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 60 days of the treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.

Trial Locations

Locations (1)

Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez; 🇦🇷 Buenos Aires, Argentina