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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
History of Changes
  Purpose

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.


Condition
Chagas Disease
Lactation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Niños R. Gutierrez de Buenos Aires:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

breastmilk; plasma


Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 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 benznidazole, 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547533

Contacts
Contact: Jaime Altcheh, MD +5411-49634122
Contact: Facundo Garcia Bournissen, MD +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            
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 Researcher, Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier: NCT01547533     History of Changes
Other Study ID Numbers: LACT-BENZNIDAZOLE
Study First Received: March 1, 2012
Last Updated: December 5, 2012
Health Authority: 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

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Benzonidazole
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013