Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00190151
Status:
TERMINATED
Last Update Posted:
2012-09-18
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-17', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of bacterial resistance in commensal flora'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic/pharmacodynamic relationship'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ciprofloxacin', 'commensal flora', 'resistance', 'Pharmacokinetic'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '28333351', 'type': 'DERIVED', 'citation': 'de Lastours V, Maugy E, Mathy V, Chau F, Rossi B, Guerin F, Cattoir V, Fantin B; CIPHARES Study Group. Ecological impact of ciprofloxacin on commensal enterococci in healthy volunteers. J Antimicrob Chemother. 2017 Jun 1;72(6):1574-1580. doi: 10.1093/jac/dkx043.'}, {'pmid': '22930806', 'type': 'DERIVED', 'citation': 'de Lastours V, Cambau E, Guillard T, Marcade G, Chau F, Fantin B. Diversity of individual dynamic patterns of emergence of resistance to quinolones in Escherichia coli from the fecal flora of healthy volunteers exposed to ciprofloxacin. J Infect Dis. 2012 Nov;206(9):1399-406. doi: 10.1093/infdis/jis511. Epub 2012 Aug 28.'}, {'pmid': '19563257', 'type': 'DERIVED', 'citation': 'Fantin B, Duval X, Massias L, Alavoine L, Chau F, Retout S, Andremont A, Mentre F. Ciprofloxacin dosage and emergence of resistance in human commensal bacteria. J Infect Dis. 2009 Aug 1;200(3):390-8. doi: 10.1086/600122.'}]}, 'descriptionModule': {'briefSummary': 'Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.', 'detailedDescription': 'Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00190151', 'briefTitle': 'Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora', 'orgStudyIdInfo': {'id': 'P031007'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ciprofloxacin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75877', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Bichat Claude Bernard, 46 rue Henri Huchard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bruno Fantin', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Beaujon, 100 boulevard du Général Leclerc, 92110 Clichy, France'}, {'name': 'Xavier Duval', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Bichat Claude Bernard, 48 rue Henri Huchard, 75877 Paris Cedex 18, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zakia IDIR', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}