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

This study is currently recruiting participants.
Verified December 2012 by Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor:
Information provided by (Responsible Party):
Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01744405
First received: December 5, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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 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 ] [ 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.


Secondary Outcome Measures:
  • 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

breastmilk; plasma


Estimated Enrollment: 12
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated 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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744405

Contacts
Contact: Jaime Altcheh, MD +5411-49624122
Contact: Facundo Garcia Bournissen, MD PhD +5411-49624122 facugb1@hotmail.com

Locations
Argentina
Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez Recruiting
Buenos Aires, Argentina, 1425
Principal Investigator: Jaime Altcheh, MD         
Sub-Investigator: Facundo Garcia Bournissen, MD PhD         
Sub-Investigator: Samanta Moroni, MD         
Sub-Investigator: Guillermo Moscatelli, MD         
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

No publications provided

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
Study First Received: December 5, 2012
Last Updated: December 5, 2012
Health Authority: Argentina: Human Research Bioethics Committee
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014