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

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ClinicalTrials.gov Identifier: NCT01547533
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Chagas Disease Lactation

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease
Study Start Date : August 2011
Primary Completion Date : June 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Facundo Garcia-Bournissen, Associate Researcher, Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier: NCT01547533     History of Changes
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 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