Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactating Women with Chagas disease | Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Benznidazole concentration in breastmilk and in plasma | 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 | at randomly selected time points during the 30 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse drug reactions in women treated with benznidazole during lactation | 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. | throughout the 30 days of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
population of young women with Chagas disease referred to our center for evaluation and treatment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Facundo Garcia Bournissen, MD PhD | Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez | Buenos Aires | Buenos Aires | 1425 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25210104 | Derived | Garcia-Bournissen F, Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Cornou L, Ballering G, Altcheh J. Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease. Arch Dis Child. 2015 Jan;100(1):90-4. doi: 10.1136/archdischild-2014-306358. Epub 2014 Sep 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
breastmilk; plasma
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |