- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01547533
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease (LACTBENZ)
March 17, 2015 updated by: Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1425
- Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
population of young women with Chagas disease referred to our center for evaluation and treatment
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Benznidazole concentration in breastmilk and in plasma
Time Frame: at randomly selected time points during the 30 days of treatment
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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 |
at randomly selected time points during the 30 days of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of adverse drug reactions in women treated with benznidazole during lactation
Time Frame: throughout the 30 days of treatment
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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.
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throughout the 30 days of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Facundo Garcia Bournissen, MD PhD, Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 1, 2012
First Submitted That Met QC Criteria
March 7, 2012
First Posted (Estimate)
March 8, 2012
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LACT-BENZNIDAZOLE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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