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

Chagas Disease Clinical Trial

— LACTNFX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744405
• Other study ID #: LACT-NIFURTIMOX
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: March 17, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Hospital de Niños R. Gutierrez de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chagas Disease
• Lactation

Locations

Country	Name	City	State
Argentina	Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Niños R. Gutierrez de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of adverse drug reactions in women treated with nifurtimox during lactation	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.	throughout the 30 days of treatment	Yes