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The investigators propose to study the transfer of nifurtimox into breastmilk of lactating women who receive the drug for the treatment of Chagas disease.
Breastmilk and blood samples will be obtained from these patients at pre-specified times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by these women to nifurtimox. This study will help clarify safety of continuing breastfeeding while receiving treatment with nifurtimox for Chagas disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactating Women with Chagas disease | Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, and who are also lactating |
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| Measure | Description | Time Frame |
|---|---|---|
| Nifurtimox 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 transfer into breastmilk, if possible. | at randomly selected, pre-specified, time points during the 30 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions in women treated with nifurtimox during lactation | Women receiving treatment with nifurtimox while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 30 days of treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion. | throughout the 30 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Population of young women with Chagas disease referred to our center for evaluation and treatment
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| 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 |
|---|---|---|---|
| 31415566 | Derived | Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Gonzalez N, Ballering G, Altcheh J, Garcia-Bournissen F. Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease. PLoS Negl Trop Dis. 2019 Aug 15;13(8):e0007647. doi: 10.1371/journal.pntd.0007647. eCollection 2019 Aug. |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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breastmilk; plasma
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |