Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 8:13 AM
Study NCT ID:
NCT03868969
Status:
UNKNOWN
Last Update Posted:
2019-03-11
First Post:
2019-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with no signs of urinary tract infection', 'timeFrame': '28 days', 'description': 'Number of patients with no signs of urinary tract infection'}], 'secondaryOutcomes': [{'measure': 'Number of patients with persistence of clinical signs of urinary tract infection', 'timeFrame': '3 days', 'description': 'Number of patients with persistence of clinical signs of urinary tract infection'}, {'measure': 'Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis', 'timeFrame': '3 months', 'description': 'Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis'}, {'measure': 'Number of patients with digestive, cutaneous disturbance', 'timeFrame': '28 days', 'description': 'Number of patients with digestive, cutaneous disturbance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (FT) per os in the treatment of documented male urinary tract infections with ESBL-producing enterobacteriaceae'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical suspicion of urinary tract infection (UTI) defined by the presence of at least one of these signs: fever \\> 38°C and/or sus-pubic pain and/or dysuria and/or pollakiuria and/or urinary burns and/or macroscopic hematuria and/or acute urinary retention and/or pain with the rectal examination and/or confusion\n* And urinary analysis with leukocyturia \\> 10 / mm3, bacteriuria \\> 10\\^3 CFU/mL with ESBL producing enterobacteriaceae and resistance associated with fluoroquinolones (FQ) and cotrimoxazole (CTX) but sensitive to fosfomycin.\n\nExclusion Criteria:\n\n* allergy to fosfomycin and/or trometamol\n* Presence of material in the urinary tract\n* Severe immunosuppression\n* Chronic prostatitis\n* Prostate abscess\n* Acute pyelonephritis\n* Hemodynamic instability\n* Chronic renal failure (clearance \\<60 mL/min)\n* Prior antibiotic therapy, with an antibiotic sensitive on the antibiotic susceptibility test except: amoxicillin - clavulanic acid, cefixime, nitrofurantoin.\n* Co-treatment with metoclopramide'}, 'identificationModule': {'nctId': 'NCT03868969', 'acronym': "FOSF'HOM", 'briefTitle': "Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': "Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)", 'orgStudyIdInfo': {'id': 'API/2017/90'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fosfomycin', 'description': 'Fosomycin tromethamine, one sachet for 21 days', 'interventionNames': ['Drug: Fosfomycin Oral Suspension']}], 'interventions': [{'name': 'Fosfomycin Oral Suspension', 'type': 'DRUG', 'description': 'Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days', 'armGroupLabels': ['Fosfomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'BOUILLER', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}