Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-01-13 @ 8:36 AM
Study NCT ID:
NCT02123628
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}, {'id': 'D005672', 'term': 'Fusidic Acid'}, {'id': 'D000069349', 'term': 'Linezolid'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D000077723', 'term': 'Cefepime'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'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': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002775', 'term': 'Cholestadienols'}, {'id': 'D002774', 'term': 'Cholestadienes'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D013843', 'term': 'Thiazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2014-04-15', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome measure was the proportion of patients of each group with remission of diabetic foot osteomyelitis at the end of follow-up.', 'timeFrame': 'one year', 'description': 'Remission was defined as the absence of any sign of infection at the initial or a contiguous site, evaluated at least one year after the end of antibiotic treatment (ie at the end of follow-up), with neither a new infectious episode nor the need for orthopedic surgery of the foot at either of these sites during the treatment and follow-up period.'}], 'secondaryOutcomes': [{'measure': 'tolerance to treatment in each group of patients', 'timeFrame': '6 or 12 weeks', 'description': 'number of episodes of adverse events attributable to the antibiotic treatment recorded in each group of patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic foot osteomyelitis, antibiotic treatment duration'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25414157', 'type': 'DERIVED', 'citation': 'Tone A, Nguyen S, Devemy F, Topolinski H, Valette M, Cazaubiel M, Fayard A, Beltrand E, Lemaire C, Senneville E. Six-week versus twelve-week antibiotic therapy for nonsurgically treated diabetic foot osteomyelitis: a multicenter open-label controlled randomized study. Diabetes Care. 2015 Feb;38(2):302-7. doi: 10.2337/dc14-1514. Epub 2014 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.', 'detailedDescription': 'The aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. Patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle).\n\nExclusion Criteria:\n\n* Patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed'}, 'identificationModule': {'nctId': 'NCT02123628', 'acronym': 'C H R O N O S', 'briefTitle': 'Antibiotic Treatment Duration for Non-Surgically-Treated Diabetic Foot Osteomyelitis', 'organization': {'class': 'OTHER', 'fullName': 'Tourcoing Hospital'}, 'officialTitle': 'Six- Versus Twelve-Week Therapy for Non-Surgically-Treated Diabetic Foot Osteomyelitis: A Multicenter Open-Label Controlled Randomized Study', 'orgStudyIdInfo': {'id': '2006-00625-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'antibiotic therapy', 'description': 'patients are treated with a 6 week-duration of antibiotic therapy :\n\n* Rifampin IP and PO twice daily, 10mg/kg /12H\n* Levofloxacin IV and PO 500-750mg once daily\n* Doxycycline PO 200mg once daily\n* Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily\n* Fusidic acid PO 500mg twice daily\n* Linezolid IV and PO 600mg twice daily\n* Ciprofloxacin IV and PO 750to 1000mg/12h\n* Cefotaxime IV 100mg/kg in three IV infusions daily\n* Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily\n* Cefepime IV ou intra-muscularly 2g /8-12h', 'interventionNames': ['Drug: duration of the antibiotic therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '12 week-duration of antibiotic therapy', 'description': 'patients are treated with a 12 week-duration of antibiotic therapy :\n\n* Rifampin IP and PO twice daily, 10mg/kg /12H\n* Levofloxacin IV and PO 500-750mg once daily\n* Doxycycline PO 200mg once daily\n* Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily\n* Fusidic acid PO 500mg twice daily\n* Linezolid IV and PO 600mg twice daily\n* Ciprofloxacin IV and PO 750to 1000mg/12h\n* Cefotaxime IV 100mg/kg in three IV infusions daily\n* Ceftriaxone IV,intramuscularly or subcutaneously 2g once daily\n* Cefepime IV ou intra-muscularly 2g /8-12h', 'interventionNames': ['Drug: duration of the antibiotic therapy']}], 'interventions': [{'name': 'duration of the antibiotic therapy', 'type': 'DRUG', 'otherNames': ['- Rifampin', '- Levofloxacin', '- Doxycycline', '- Trimethoprim- sulfamethoxazole', '- Fusidic acid', '- Linezolid', '- Ciprofloxacin', '- Cefotaxime', '- Ceftriaxone', '- Cefepime'], 'armGroupLabels': ['12 week-duration of antibiotic therapy', 'antibiotic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59200', 'city': 'Tourcoing', 'state': 'Nord', 'country': 'France', 'facility': 'Dron Hospital', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}], 'overallOfficials': [{'name': 'Eric M Senneville, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dron Hospital of Tourcoing France'}, {'name': 'Alina Tone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dron Hospital Tourcoing France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tourcoing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}