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

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.

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

Conditions
-----------------
Chagas Disease, Lactation

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lactating Women with Chagas disease<br>Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, and who are also lactating | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nifurtimox concentration in breastmilk and in plasma | 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. | at randomly selected, pre-specified, time points during the 30 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in women treated with nifurtimox during lactation | 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. | throughout the 30 days of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chagas disease, lactation, breastmilk, postpartum period, infants, pediatric clinical pharmacology, developmental clinical pharmacology, parasitology, trypanosoma cruzi, nifurtimox