Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease (LACTBENZ)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease|
- 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
- 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.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated 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
|Contact: Jaime Altcheh, MD||+5411-49634122|
|Contact: Facundo Garcia Bournissen, MDfirstname.lastname@example.org|
|Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez||Recruiting|
|Buenos Aires, Argentina, 1425|
|Principal Investigator: Jaime Altcheh, MD|
|Sub-Investigator: Facundo Garcia Bournissen, MD|
|Sub-Investigator: Samanta Moroni, MD|
|Sub-Investigator: Guillermo Moscatelli, MD|
|Principal Investigator:||Facundo Garcia Bournissen, MD PhD||Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET|