Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
Study NCT ID:
NCT04967859
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2018-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Patients will be allocated to two groups randomly (draw), according to the prescribed topical treatment (gentamicin or placebo). The randomization protocol will be generated by an individual other than the patients' clinical follow-up using specific software (randomization). . The randomization list as well as the identification of the bottles and the uniformity of the packages will remain under the care of the researchers who are not familiar with the patients' clinical follow-up"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1 (control): Patients using placebo ointment in ES Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-18', 'studyFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2021-07-18', 'lastUpdatePostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of exit-site infection', 'timeFrame': '1 years', 'description': 'Rates of exit-site infection (measured in events per 1,000 catheter-days)'}, {'measure': 'Rates of catheter-related bloodstream infections', 'timeFrame': '1 years', 'description': 'Rates of catheter-related bloodstream infections (measured in events per 1,000 catheter-days)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemodialysis;', 'tunneled catheter', 'central venous catheters', 'infections', 'prevention.'], 'conditions': ['Hemodialysis Catheter Infection']}, 'referencesModule': {'references': [{'pmid': '26498416', 'type': 'BACKGROUND', 'citation': 'National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.'}, {'pmid': '23859190', 'type': 'BACKGROUND', 'citation': 'Camins BC. Prevention and treatment of hemodialysis-related bloodstream infections. Semin Dial. 2013 Jul-Aug;26(4):476-81. doi: 10.1111/sdi.12117.'}, {'pmid': '18413621', 'type': 'BACKGROUND', 'citation': 'James MT, Conley J, Tonelli M, Manns BJ, MacRae J, Hemmelgarn BR; Alberta Kidney Disease Network. Meta-analysis: antibiotics for prophylaxis against hemodialysis catheter-related infections. Ann Intern Med. 2008 Apr 15;148(8):596-605. doi: 10.7326/0003-4819-148-8-200804150-00004.'}, {'pmid': '25156111', 'type': 'BACKGROUND', 'citation': 'Zacharioudakis IM, Zervou FN, Arvanitis M, Ziakas PD, Mermel LA, Mylonakis E. Antimicrobial lock solutions as a method to prevent central line-associated bloodstream infections: a meta-analysis of randomized controlled trials. Clin Infect Dis. 2014 Dec 15;59(12):1741-9. doi: 10.1093/cid/ciu671. Epub 2014 Aug 25.'}, {'pmid': '27039404', 'type': 'BACKGROUND', 'citation': 'Wang Y, Ivany JN, Perkovic V, Gallagher MP, Woodward M, Jardine MJ. Anticoagulants and antiplatelet agents for preventing central venous haemodialysis catheter malfunction in patients with end-stage kidney disease. Cochrane Database Syst Rev. 2016 Apr 4;4(4):CD009631. doi: 10.1002/14651858.CD009631.pub2.'}, {'pmid': '24278133', 'type': 'BACKGROUND', 'citation': 'Liu Y, Zhang AQ, Cao L, Xia HT, Ma JJ. Taurolidine lock solutions for the prevention of catheter-related bloodstream infections: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2013 Nov 21;8(11):e79417. doi: 10.1371/journal.pone.0079417. eCollection 2013.'}, {'pmid': '24125729', 'type': 'BACKGROUND', 'citation': 'Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.'}, {'pmid': '20227787', 'type': 'BACKGROUND', 'citation': 'Snaterse M, Ruger W, Scholte Op Reimer WJ, Lucas C. Antibiotic-based catheter lock solutions for prevention of catheter-related bloodstream infection: a systematic review of randomised controlled trials. J Hosp Infect. 2010 May;75(1):1-11. doi: 10.1016/j.jhin.2009.12.017. Epub 2010 Mar 15.'}, {'pmid': '18498236', 'type': 'BACKGROUND', 'citation': 'Yahav D, Rozen-Zvi B, Gafter-Gvili A, Leibovici L, Gafter U, Paul M. Antimicrobial lock solutions for the prevention of infections associated with intravascular catheters in patients undergoing hemodialysis: systematic review and meta-analysis of randomized, controlled trials. Clin Infect Dis. 2008 Jul 1;47(1):83-93. doi: 10.1086/588667.'}, {'pmid': '24970878', 'type': 'BACKGROUND', 'citation': 'Landry D, Braden G. Reducing catheter-related infections in hemodialysis patients. Clin J Am Soc Nephrol. 2014 Jul;9(7):1156-9. doi: 10.2215/CJN.04700514. Epub 2014 Jun 26. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Chronic kidney disease (CKD) is a major public health problem worldwide, with a significant increase in the number of patients treated with dialysis and renal transplantation. Hemodialysis (HD) is the most widely used dialysis therapy in the world, and adequate vascular access is required. The central venous catheter (CVC), although not considered the ideal vascular access, is still widely used. Its use has a strong relation with access-related infection, whether it is an exit orifice (IES), a tunnel and the most severe, the bloodstream (BSI). Consequently CVC contributes to patients' morbidity and mortality in HD, as well as to the high cost of hemodialysis treatment.\n\nTo compare the use of 0.1% topical gentamicin with the use of placebo in the exit site (ES) of tunneled catheters in patients in chronic HD regarding the reduction in IES and BSI rates and to identify the induction of bacterial resistance to gentamicin.", 'detailedDescription': 'A randomized, double-blind clinical trial comparing the use of 0.1% gentamicin versus placebo in the ES of tunnelled catheters for hemodialysis in the prevalence and density of incidence of IES and BSI. Patients will be allocated into two groups randomly: Group 1 (control): Patients using placebo ointment in ES; Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* incident and prevalent patients on hemodialysis\n* Tunnelled catheter implant within 90 days of study initiation\n\nExclusion Criteria:\n\n* patients under 18 years of age\n* pregnant women\n* other types of access for dialysis other than tunnelled catheters\n* course of infection at the time of initiation of the study.'}, 'identificationModule': {'nctId': 'NCT04967859', 'briefTitle': 'Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis: a Randomized, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': '98328718.0.0000.5411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1 (control):', 'description': 'Patients using placebo ointment at the exit site of the hemodialysis catheter', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (intervention)', 'description': 'Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter', 'interventionNames': ['Drug: 0.1% gentamicin']}], 'interventions': [{'name': '0.1% gentamicin', 'type': 'DRUG', 'description': 'Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter', 'armGroupLabels': ['Group 2 (intervention)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients using placebo ointment at the exit site of the hemodialysis catheter', 'armGroupLabels': ['Group 1 (control):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18.618-970', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}], 'overallOfficials': [{'name': 'Daniela Ponce', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Camille Pereira Caetano', 'investigatorAffiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}}}}