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Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease

NCT01744405 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2015-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Chagas Disease
  • Lactation

Sponsors & Collaborators

  • Hospital de Niños R. Gutierrez de Buenos Aires

    lead OTHER

Principal Investigators

  • Facundo Garcia Bournissen, MD PhD · Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-12-31
Completion
2015-03-31

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744405 on ClinicalTrials.gov