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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744405
First Posted: December 6, 2012
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires
  Purpose

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.


Condition
Chagas Disease Lactation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease

Resource links provided by NLM:


Further study details as provided by Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires:

Primary Outcome Measures:
  • Nifurtimox concentration in breastmilk and in plasma [ Time Frame: at randomly selected, pre-specified, 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 transfer into breastmilk, if possible.


Secondary Outcome Measures:
  • Incidence of adverse drug reactions in women treated with nifurtimox during lactation [ Time Frame: throughout the 30 days of treatment ]
    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
breastmilk; plasma

Enrollment: 12
Study Start Date: December 2012
Study Completion Date: March 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, and who are also lactating

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population of young women with Chagas disease referred to our center for evaluation and treatment
Criteria

Inclusion Criteria:

  • Lactating women with Chagas disease, not treated before
  • Use of contraception

Exclusion Criteria:

  • History of allergy to nifurtimox 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744405


Locations
Argentina
Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Buenos Aires, Argentina, 1425
Sponsors and Collaborators
Hospital de Niños R. Gutierrez de Buenos Aires
Investigators
Principal Investigator: Facundo Garcia Bournissen, MD PhD Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
  More Information

Responsible Party: Facundo Garcia-Bournissen, Associate Resesarcher, Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier: NCT01744405     History of Changes
Other Study ID Numbers: LACT-NIFURTIMOX
First Submitted: December 5, 2012
First Posted: December 6, 2012
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires:
Chagas disease
lactation
breastmilk
postpartum period
infants
pediatric clinical pharmacology
developmental clinical pharmacology
parasitology
trypanosoma cruzi
nifurtimox

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Nifurtimox
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents