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

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.

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Key information

Conditions

Chagas Disease Behavior Breast Feeding Euglenozoa Infections Feeding Behavior Infections Lactation Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez

Buenos Aires, 1425, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Other

Registry information

Acronym: LACTNFX

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2015
First posted: Dec 6, 2012
Registry last updated: Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed