Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-06 @ 1:40 AM
Study NCT ID:
NCT02423759
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2015-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D005839', 'term': 'Gentamicins'}], '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'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-02', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurrence of post procedure infectious complications', 'timeFrame': '2 weeks', 'description': 'occurrence of post procedure infectious complications (e.g urosepsis and local genital or prostate infectious complications). Sepsis is identified as occurrence of two or more of SIRS criteria.'}], 'secondaryOutcomes': [{'measure': 'flouroquinolones resistance in rectal carriage', 'timeFrame': '2 weeks', 'description': 'identification of the prevalence of flouroquinolones resistance in rectal carriage in this subset of patients and post procedure non-infectious complications.'}, {'measure': 'post procedure non-infectious complications', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chemoprevention'], 'conditions': ['Benign Prostate Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether changing antibiotic prophylaxis from fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted antibiotic prophylaxis according to rectal swab culture would influence infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.', 'detailedDescription': "Introduction Transrectal ultrasound (TRUS) guided prostate biopsy is the standard procedure for the histological diagnosis and grading of prostate cancer that consequently help in providing the appropriate line of treatment. Risks of infectious complications post TRUS-guided biopsy have increased in the last years.\n\nIn their study, a total of 5798 TRUS-guided biopsies performed between 2002 and 2011. Increased incidence of infectious complications is noted from 0.52 infections per 100 biopsies between 2002 and 2009 to 2.15 infections per 100 biopsies between 2010 and 2011 (P\\< 0.001). The commonest organism found to be responsible for these infectious complications is Escherichia coli (E. Coli).\n\nThe American Urological Association best practice policy statement recommends antibiotic prophylaxis prior to transrectal prostate biopsy. The current practice is to give patients a dose of an oral fluoroquinolone (FQ) 30 to 60 minutes before biopsy and to be continued for 2 to 3 days after.\n\nRecent studies show that 2% of patients will develop febrile urinary tract infection or even urosepsis and require hospitalization for intravenous antibiotics . There is considerable concern regarding the rising incidence of community-acquired antibiotic-resistant organisms.\n\nIt is proposed that resistant organisms are introduced into the bladder and the blood stream from the rectum during the procedure that's why patients already colonized with these resistant organisms may be at higher risk. Thereby, some authors suggest a targeted rectal swab culture before (TRUS)-guided biopsy then giving the appropriate antibiotic prophylaxis aiming at reducing post biopsy infection rates while minimizing unnecessary broad-spectrum antibiotic use.\n\nRetrospective data showed that septicemia was seen in 24 of 300 (8%) and 15 of 897 (1.7%) in patients receiving peri-procedure ciprofloxacin alone and patients receiving ciprofloxacin plus single IV dose of amikacin injection respectively (p=0.001). E. Coli resistant to quinolones was responsible for 33 of 39 (84.6%) septicemic cases. In a retrospective study in UK, 12.9% developed infectious complications following prostate biopsy in patients receiving co-amoxiclav and gentamycin.\n\nIn another retrospective study, hospitalization rate due to post-biopsy infections was 3.8% compared to 0.6% (p=0.001) in patients receiving the standard ciprofloxacin and augmented prophylaxis with ciprofloxacin plus single IM 80mg gentamycin respectively. Of the admitted patients who received standard prophylaxis, 73% had fluoroquinolone resistant E. Coli urinary infection and/or bacteremia and only 9% had strains resistant to gentamicin. Multivariate analysis showed that the standard regimen was significantly associated with hospital admission due to post-biopsy infection. The augmented regimen resulted in a cost savings of $15,700 per 100 patients compared to the standard regimen.\n\nDiabetes was found in 4% of the fluoroquinolone sensitive group vs 14.7% of the resistant group (p \\< 0.001). Biopsy history was not associated with resistance.\n\nUrosepsis is a systemic reaction of the body to a bacterial infection of the urogenital organs with the risk of life-threatening events including shock. Systemic inflammatory response syndrome (SIRS) criteria are defined as 2 or more of the following variables; increase in body temperature to 38°C or more, heart rate of more than 90 beats per minute, respiratory rate of more than 20 per minute or arterial carbon dioxide tension (PaCO2) less than 32mm Hg and abnormal white blood cell count (\\>12,000/µL or \\< 4,000/µL) Aim of the work; The aim of the study is to evaluate whether changing antibiotic prophylaxis from fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted antibiotic prophylaxis according to rectal swab culture would influence infectious complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Prothrombin concentration \\> 70%\n2. Platelet count \\> 100.000/cm\n\nExclusion Criteria:\n\n1. Acute prostatitis (positive symptoms and signs)\n2. Patients with compromised renal function (serum creatinine \\>1.6 mg/dl)\n3. Uncontrolled DM\n4. Patients on immunosuppressive therapy\n5. Active steroid intake\n6. Untreated bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT02423759', 'briefTitle': 'A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Rectal Swab Culture Based Chemoprophylaxis Versus Combined Single-Shot Gentamycin and Ciprofloxacin Versus Ciprofloxacin Alone for Peri-procedure Chemoprophylaxis During Transrectal Prostate Biopsy.', 'orgStudyIdInfo': {'id': 'MANS-2015-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ciprofloxacin', 'description': 'standard chemoprophylaxis \\[500mg ciprofloxacin twice daily for 3 days\\]', 'interventionNames': ['Drug: ciprofloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'ciprofloxacin and gentamycine', 'description': 'Augmented Chemoprophylaxis \\[standard chemoprophylaxis plus 160mg\\]', 'interventionNames': ['Drug: ciprofloxacin and gentamycine']}, {'type': 'EXPERIMENTAL', 'label': 'culture based chemoprophylaxis', 'description': 'Patients will receive antibiotic according to rectal swab culture at time of biopsy and then after for 3 days.', 'interventionNames': ['Drug: culture based chemoprophylaxis']}], 'interventions': [{'name': 'ciprofloxacin', 'type': 'DRUG', 'otherNames': ['standard chemoprophylaxis'], 'description': '500mg ciprofloxacin twice daily starting the day before biopsy and continued for 3 days after', 'armGroupLabels': ['ciprofloxacin']}, {'name': 'ciprofloxacin and gentamycine', 'type': 'DRUG', 'otherNames': ['standard chemoprophylaxis plus gentamicin'], 'description': 'standard chemoprophylaxis plus gentamicin 160mg intramuscular once just before the biopsy', 'armGroupLabels': ['ciprofloxacin and gentamycine']}, {'name': 'culture based chemoprophylaxis', 'type': 'DRUG', 'description': 'Patients will receive antibiotic according to rectal swab culture at time of biopsy and then after for 3 days.', 'armGroupLabels': ['culture based chemoprophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Urology and Nprhology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed M Elshal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Elshal', 'investigatorAffiliation': 'Mansoura University'}}}}