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

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.

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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 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

Treatment and study plan

Primary outcomes

Benznidazole concentration in breastmilk and in plasma

Time frame: 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 outcomes

incidence of adverse drug reactions in women treated with benznidazole during lactation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Other

Registry information

Official study title

Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease

Acronym: LACTBENZ

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 8, 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.

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Completed