Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02547103
Status:
UNKNOWN
Last Update Posted:
2019-07-29
First Post:
2015-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 354}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety profiles', 'timeFrame': '24 months', 'description': 'Safety of investigational medicinal products related to potential harm (e.g. participant survival, hospitalization, and emergency visit)'}], 'primaryOutcomes': [{'measure': 'Incidence of PD-related infections', 'timeFrame': '24 months', 'description': 'Peritonitis or exit-site and tunnel infection'}], 'secondaryOutcomes': [{'measure': 'Incidence of infection-related catheter removal', 'timeFrame': '24 months', 'description': 'Peritonitis or exit-site and tunnel infection-related catheter removal'}, {'measure': 'Incidence of hospitalization due to PD-related infection', 'timeFrame': '24 months'}, {'measure': 'Incidence of PD technical failure (change of modal of dialysis)', 'timeFrame': '24 months', 'description': 'change of modal of dialysis'}, {'measure': 'Incidence of death due to PD-related infection', 'timeFrame': '24 months', 'description': 'Death due to peritonitis or exit-site and tunnel infection'}, {'measure': 'Rate of Staphylococcus aureus colonization', 'timeFrame': '24 months', 'description': 'Incidence of nasal or exit-site S. aureus colonization'}, {'measure': 'Changes in health-related quality of life', 'timeFrame': '24 months', 'description': 'Using the Kidney Disease Quality of Life-36 (KDQOL-36), EuroQoL-5 dimension-5 level (EQ-5D-5L)'}, {'measure': 'Number of participants with depression', 'timeFrame': '24 months', 'description': 'Using the Beck Depression Inventory II (BDI-II)'}, {'measure': 'Changes in medication adherence', 'timeFrame': '24 months', 'description': 'Using (i) directly observed to record the use of investigational medicinal products via return plastic sachets and ointment tubes; (ii) global rating on medication adherence by visual analog scale; and (iii) Medication-taking behavior measure for Thai patients (MTB-Thai questionnaire'}, {'measure': 'Total healthcare costs', 'timeFrame': '24 months', 'description': 'Direct medical costs, direct non-medical costs, and indirect costs'}, {'measure': 'Incidence of skin reactions', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chlorhexidine gluconate', 'Mupirocin ointment', 'Normal saline', 'Peritonitis', 'Peritoneal dialysis'], 'conditions': ['End Stage Renal Disease', 'Peritoneal Dialysis']}, 'referencesModule': {'references': [{'pmid': '31856900', 'type': 'DERIVED', 'citation': 'Nochaiwong S, Ruengorn C, Noppakun K, Panyathong S, Dandecha P, Sood MM, Saenjum C, Awiphan R, Sirilun S, Mongkhon P, Chongruksut W, Thavorn K; Thai Renal Outcomes Research (THOR) Investigators. Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol. Trials. 2019 Dec 19;20(1):754. doi: 10.1186/s13063-019-3953-8.'}], 'seeAlsoLinks': [{'url': 'http://www.pharmacy.cmu.ac.th', 'label': 'Faculty of Pharmacy, Chiang Mai University'}]}, 'descriptionModule': {'briefSummary': 'This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed up 24 months or completion of PD. The primary outcome is PD-related infection (PD-related peritonitis of exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. Costs include providers and patients expenses. The utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipated nephrologists and health care professional involving to PD in decision-making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.', 'detailedDescription': 'Peritoneal dialysis (PD) is one of renal replacement therapy used for end-stage renal disease. Since 2011, there has been increasing numbers of patients under "PD First" policy of the Thai government. The most common PD related complication is PD-related infection categorized PD-related peritonitis, and exit site and tunnel infection. Although possible to treat PD-related infection, the incidence of technical failure and death due to peritonitis are still high in Thailand. PD-related infections mainly caused by Staphylococcus aureus. To prevent PD-related infection, cleaning with aseptic solvents using aseptic technique and prevent infection by prescribing prophylactic antibiotics are recommended. The International Society for Peritoneal Dialysis (ISPD) has recommended position statement of the regular use of mupirocin ointment around the catheter exits point and apply in nasal cavity. However, there is rising concern of long term use of mupirocin for mupirocin resistance of S. aureus. CHG is antiseptic use in clinical practice. It can coat at least 12 hours on skin and has anti-bacterial covered in both grams negative and positive. Several meta-analysis studies showed effectiveness of CHG in the prevention of hospitals infection i.e. reduces catheter-related sepsis, postoperative infection, and microbial resistance. According to PD-related infection, CHG has very little evidence of its effectiveness. This pilot study aims to evaluate effectiveness, safety, and cost-utility of CHG-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline and povidone-iodine) with aseptic technique in prevention of PD-related infections. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths. They will be followed up 24 months or completetion of PD. The primary outcome is PD-related infection (PD-related peritonitis or exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. For cost-utility analysis, costs include providers and patients expenses. The Utility is assessed using EQ-5D-5L.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients with end-stage renal disease who were undergoing peritoneal dialysis; either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD)\n\nExclusion Criteria:\n\n1. History of psychological illness or condition that interferes with the ability to understand or comply with the requirements of the study\n2. Recent (within 1 month) exit-site or tunnel infection, or peritonitis\n3. Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin\n4. Current or recent (within 1 month) treatment with antibiotics administered by any route\n5. Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant S. aureus'}, 'identificationModule': {'nctId': 'NCT02547103', 'acronym': 'COSMO-PD', 'briefTitle': 'Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Efficacy and Safety of Local Application of Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection: A Double-Blind, Stratified Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'THOR-PD Group'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine gluconate', 'description': 'Chlorhexidine gluconate-soaked cloths, clean topical area around catheter exit site with CHG 2% soaked cloths', 'interventionNames': ['Other: Chlorhexidine gluconate-soaked cloths']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal saline (usual care)', 'description': 'Normal saline, clean topical area around catheter exit site', 'interventionNames': ['Other: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mupirocin ointment', 'description': 'Mupirocin ointment 2%, clean topical area around catheter exit site with Mupirocin ointment', 'interventionNames': ['Other: mupirocin ointment']}], 'interventions': [{'name': 'Chlorhexidine gluconate-soaked cloths', 'type': 'OTHER', 'armGroupLabels': ['Chlorhexidine gluconate']}, {'name': 'Normal saline', 'type': 'OTHER', 'armGroupLabels': ['Normal saline (usual care)']}, {'name': 'mupirocin ointment', 'type': 'OTHER', 'armGroupLabels': ['Mupirocin ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Kajohnsak Noppakun, Nephrologist', 'role': 'CONTACT', 'email': 'knoppaku@med.cmu.ac.th', 'phone': '+6653946452'}, {'name': 'Chayutthaphong Chaisai, Pharmacist', 'role': 'CONTACT', 'email': 'c.chayutthaphong@gmail.com', 'phone': '+6653941507'}], 'facility': 'Maharaj Nakorn Chiang Mai Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'centralContacts': [{'name': 'Surapon Nochaiwong', 'role': 'CONTACT', 'email': 'surapon.nochaiwong@gmail.com', 'phone': '+6653991507'}, {'name': 'Chidchanok Ruengorn', 'role': 'CONTACT', 'email': 'mei.ruengorn@gmail.com', 'phone': '+6653991507'}], 'overallOfficials': [{'name': 'Chidchanok Ruengorn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Pharmacy CMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Systems Research Institute,Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Faculty of Pharmacy', 'investigatorFullName': 'Chidchanok Ruengorn', 'investigatorAffiliation': 'Chiang Mai University'}}}}