Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease (LACTNFX)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease|
- Nifurtimox concentration in breastmilk and in plasma [ Time Frame: at randomly selected, pre-specified, 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 transfer into breastmilk, if possible.
- Incidence of adverse drug reactions in women treated with nifurtimox during lactation [ Time Frame: throughout the 30 days of treatment ] [ Designated as safety issue: Yes ]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.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||December 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||December 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 nifurtimox, and who are also lactating
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744405
|Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez|
|Buenos Aires, Argentina, 1425|
|Principal Investigator:||Facundo Garcia Bournissen, MD PhD||Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET|