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

This study has been completed.
Information provided by (Responsible Party):
Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires Identifier:
First received: March 1, 2012
Last updated: March 17, 2015
Last verified: March 2015
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.

Chagas Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease

Resource links provided by NLM:

Further study details as provided by Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Biospecimen Retention:   Samples Without DNA
breastmilk; plasma

Enrollment: 10
Study Start Date: August 2011
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
population of young women with Chagas disease referred to our center for evaluation and treatment

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
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Please refer to this study by its identifier: NCT01547533

Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Buenos Aires, Argentina, 1425
Sponsors and Collaborators
Hospital de Niños R. Gutierrez de Buenos Aires
Principal Investigator: Facundo Garcia Bournissen, MD PhD Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Facundo Garcia-Bournissen, Associate Researcher, Hospital de Niños R. Gutierrez de Buenos Aires Identifier: NCT01547533     History of Changes
Study First Received: March 1, 2012
Last Updated: March 17, 2015

Keywords provided by Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires:
Chagas disease
postpartum period
pediatric clinical pharmacology
developmental clinical pharmacology
trypanosoma cruzi

Additional relevant MeSH terms:
Chagas Disease
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents processed this record on May 25, 2017