Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Hospital de Niños R. Gutierrez de Buenos Aires.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires Identifier:
First received: December 5, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

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.

Chagas Disease

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)
Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, and who are also lactating


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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01744405

Contact: Jaime Altcheh, MD +5411-49624122
Contact: Facundo Garcia Bournissen, MD PhD +5411-49624122

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
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 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
postpartum period
pediatric clinical pharmacology
developmental clinical pharmacology
trypanosoma cruzi

Additional relevant MeSH terms:
Chagas Disease
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents processed this record on February 27, 2015