Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT01547533
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2012-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014355', 'term': 'Chagas Disease'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'breastmilk; plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Benznidazole concentration in breastmilk and in plasma', 'timeFrame': 'at randomly selected time points during the 30 days of treatment', 'description': '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.\n\nBreastmilk concentrations will be used to calculate potential infant exposure through breastmilk to the medication (benznidazole) taken by the mother'}], 'secondaryOutcomes': [{'measure': 'incidence of adverse drug reactions in women treated with benznidazole during lactation', 'timeFrame': 'throughout the 30 days of treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chagas disease', 'lactation', 'breastmilk', 'postpartum period', 'infants', 'pediatric clinical pharmacology', 'developmental clinical pharmacology', 'parasitology', 'trypanosoma cruzi'], 'conditions': ['Chagas Disease', 'Lactation']}, 'referencesModule': {'references': [{'pmid': '25210104', 'type': 'DERIVED', 'citation': 'Garcia-Bournissen F, Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Cornou L, Ballering G, Altcheh J. Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease. Arch Dis Child. 2015 Jan;100(1):90-4. doi: 10.1136/archdischild-2014-306358. Epub 2014 Sep 10.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'population of young women with Chagas disease referred to our center for evaluation and treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lactating women with Chagas disease, not treated before\n* Use of contraception\n\nExclusion Criteria:\n\n* History of allergy to benznidazole or its excipients\n* Pregnancy\n* Significant heart involvement (due to Chagas disease)\n* Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator'}, 'identificationModule': {'nctId': 'NCT01547533', 'acronym': 'LACTBENZ', 'briefTitle': 'Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Niños R. Gutierrez de Buenos Aires'}, 'officialTitle': 'Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease', 'orgStudyIdInfo': {'id': 'LACT-BENZNIDAZOLE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lactating Women with Chagas disease', 'description': 'Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez'}], 'overallOfficials': [{'name': 'Facundo Garcia Bournissen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Niños R. Gutierrez de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Researcher', 'investigatorFullName': 'Facundo Garcia-Bournissen', 'investigatorAffiliation': 'Hospital de Niños R. Gutierrez de Buenos Aires'}}}}