Chagas Disease, Lactation
Conditions
Keywords
Chagas disease, lactation, breastmilk, postpartum period, infants, pediatric clinical pharmacology, developmental clinical pharmacology, parasitology, trypanosoma cruzi
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.
Interventions
None listed
Sponsors
Hospital de Niños R. Gutierrez de Buenos Aires
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Benznidazole concentration in breastmilk and in plasma | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse drug reactions in women treated with benznidazole during lactation | 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. |
Countries
Argentina
Outcome results
None listed