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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01744405

Acronym

LACTNFX

Enrollment

Registered

2012-12-06

Start date

2012-12-31

Completion date

2015-03-31

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chagas Disease, Lactation

Keywords

Chagas disease, lactation, breastmilk, postpartum period, infants, pediatric clinical pharmacology, developmental clinical pharmacology, parasitology, trypanosoma cruzi, nifurtimox

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Nifurtimox concentration in breastmilk and in plasma	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.

Secondary

Measure	Time frame	Description
Incidence of adverse drug reactions in women treated with nifurtimox during lactation	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.

Countries

Argentina

Outcome results