Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease (LACTBENZ)

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:
NCT01547533
First received: March 1, 2012
Last updated: December 5, 2012
Last verified: December 2012

March 1, 2012
December 5, 2012
August 2011
June 2013   (final data collection date for primary outcome measure)
Benznidazole concentration in breastmilk and in plasma [ Time Frame: at randomly selected 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 trasfer into breastmilk, if possible.

Breastmilk concentrations will be used to calculate potential infant exposure through breastmilk to the medication (benznidazole) taken by the mother

Same as current
Complete list of historical versions of study NCT01547533 on ClinicalTrials.gov Archive Site
incidence of adverse drug reactions in women treated with benznidazole during lactation [ Time Frame: throughout the 30 days of treatment ] [ Designated as safety issue: Yes ]
Women receiving treatment with benznidazole while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 60 days of the treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.
Same as current
Not Provided
Not Provided
 
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease
Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease

The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

breastmilk; plasma

Non-Probability Sample

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

  • Chagas Disease
  • Lactation
Not Provided
Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • History of allergy to benznidazole 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
Female
18 Years to 40 Years
No
Contact: Jaime Altcheh, MD +5411-49634122
Contact: Facundo Garcia Bournissen, MD +5411-49624122 facugb1@hotmail.com
Argentina
 
NCT01547533
LACT-BENZNIDAZOLE
Yes
Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires
Hospital de Niños R. Gutierrez de Buenos Aires
Not Provided
Principal Investigator: Facundo Garcia Bournissen, MD PhD Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
Hospital de Niños R. Gutierrez de Buenos Aires
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP