Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-23 @ 6:59 AM
Study NCT ID:
NCT01744405
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2012-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of Nifurtimox 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': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nifurtimox concentration in breastmilk and in plasma', 'timeFrame': 'at randomly selected, pre-specified, 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 transfer into breastmilk, if possible.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse drug reactions in women treated with nifurtimox during lactation', 'timeFrame': 'throughout the 30 days of treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chagas disease', 'lactation', 'breastmilk', 'postpartum period', 'infants', 'pediatric clinical pharmacology', 'developmental clinical pharmacology', 'parasitology', 'trypanosoma cruzi', 'nifurtimox'], 'conditions': ['Chagas Disease', 'Lactation']}, 'referencesModule': {'references': [{'pmid': '31415566', 'type': 'DERIVED', 'citation': 'Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Gonzalez N, Ballering G, Altcheh J, Garcia-Bournissen F. Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease. PLoS Negl Trop Dis. 2019 Aug 15;13(8):e0007647. doi: 10.1371/journal.pntd.0007647. eCollection 2019 Aug.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to study the transfer of nifurtimox into breastmilk of lactating women who receive the drug for the treatment of Chagas disease.\n\nBreastmilk 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.'}, '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 nifurtimox 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': 'NCT01744405', 'acronym': 'LACTNFX', 'briefTitle': 'Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Niños R. Gutierrez de Buenos Aires'}, 'officialTitle': 'Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease', 'orgStudyIdInfo': {'id': 'LACT-NIFURTIMOX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lactating Women with Chagas disease', 'description': 'Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, 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 Resesarcher', 'investigatorFullName': 'Facundo Garcia-Bournissen', 'investigatorAffiliation': 'Hospital de Niños R. Gutierrez de Buenos Aires'}}}}