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

NCT01744405 | Completed

• 1 other identifier: LACT-NIFURTIMOX
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chagas disease; lactation; breastmilk; postpartum period; infants; pediatric clinical pharmacology; developmental clinical pharmacology; parasitology; trypanosoma cruzi; nifurtimox

Outcome Measures

Primary Outcomes (1)

• Nifurtimox concentration in breastmilk and in plasma

  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.

  at randomly selected, pre-specified, time points during the 30 days of treatment

Secondary Outcomes (1)

• Incidence of adverse drug reactions in women treated with nifurtimox during lactation

  throughout the 30 days of treatment

Study Arms (1)

Lactating Women with Chagas disease

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Population of young women with Chagas disease referred to our center for evaluation and treatment

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Study Sites (1)

Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez

Buenos Aires, Buenos Aires, 1425, Argentina

Location

Related Publications (1)

• Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Gonzalez N, Ballering G, Altcheh J, Garcia-Bournissen F. Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease. PLoS Negl Trop Dis. 2019 Aug 15;13(8):e0007647. doi: 10.1371/journal.pntd.0007647. eCollection 2019 Aug.

  PMID: 31415566 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

breastmilk; plasma

MeSH Terms

Conditions

Chagas Disease; Breast Feeding

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Feeding Behavior; Behavior

Study Officials

• Facundo Garcia Bournissen, MD PhD

  Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Resesarcher

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

AR (1)