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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.


Detailed Summary:
Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of adverse drug reactions in women treated with nifurtimox during lactation [ Time Frame: throughout the 30 days of treatment ]

Women receiving treatment with nifurtimox while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 30 days of treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.


Original Secondary Outcome: Same as current

Information By: Hospital de Niños R. Gutierrez de Buenos Aires

Dates:
Date Received: December 5, 2012
Date Started: December 2012
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015