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
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease
Primary Outcome Measures:
- Benznidazole concentration in breastmilk and in plasma [ Time Frame: at randomly selected time points during the 30 days of treatment ] [ Designated as safety issue: No ]
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
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- incidence of adverse drug reactions in women treated with benznidazole during lactation [ Time Frame: throughout the 30 days of treatment ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| 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)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
population of young women with Chagas disease referred to our center for evaluation and treatment
- Lactating women with Chagas disease, not treated before
- Use of contraception
- History of allergy to benznidazole or its excipients
- 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 ClinicalTrials.gov identifier: NCT01547533
|Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
|Buenos Aires, Argentina, 1425 |
Hospital de Niños R. Gutierrez de Buenos Aires
||Facundo Garcia Bournissen, MD PhD
||Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Facundo Garcia-Bournissen, Associate Researcher, Hospital de Niños R. Gutierrez de Buenos Aires
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 1, 2012
||March 17, 2015
||Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Keywords provided by Hospital de Niños R. Gutierrez de Buenos Aires:
pediatric clinical pharmacology
developmental clinical pharmacology
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2016
Physiological Effects of Drugs