Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05959018
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2023-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy & Cost Effectiveness of Antimicrobial-impregnated CVCs in CLABSI Prevention in a Malaysia Adult ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-22', 'size': 718907, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-09T08:49', 'hasProtocol': True}, {'date': '2023-03-22', 'size': 382847, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-28T21:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-07-22', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central line-associated bloodstream infection (CLABSI) rate', 'timeFrame': 'Through study completion, tentatively up to 1 year', 'description': 'CLABSI cases per 1000 catheter days'}], 'secondaryOutcomes': [{'measure': 'ICU Length of stay of patients diagnosed with CLABSI', 'timeFrame': 'Through study completion, tentatively up to 1 year', 'description': 'Days of ICU stay'}, {'measure': 'Healthcare costs of patients diagnosed with CLABSI', 'timeFrame': 'Through study completion, tentatively up to 1 year', 'description': 'Healthcare costs, expressed in Malaysian Ringgit (MYR)'}, {'measure': 'Percentages of specific bacterial species isolated from patients diagnosed with CLABSI', 'timeFrame': 'Through study completion, tentatively up to 1 year', 'description': 'Percentages of specific bacterial species isolated from patients diagnosed with CLABSI\n\nExamples:\n\n* Gram positive organisms: Coagulase negative Staphylococci (CONS), Enterococci, Staphylococcus aureus\n* Gram negative organisms: Klebsiella, Pseudomonas, Escherichia coli, Acinetobacter'}, {'measure': 'Percentages of antimicrobial resistance pattern groups among bacterial species isolated from patients diagnosed with CLABSI', 'timeFrame': 'Through study completion, tentatively up to 1 year', 'description': 'Percentages of antimicrobial resistance pattern groups among bacterial species isolated from patients diagnosed with CLABSI\n\nExamples:\n\n* Methicillin Resistant Staphylococcus aureus (MRSA)\n* Extended-spectrum beta-lactamase (ESBL) producing Enterobacterales\n* Carbapenam-resistant Enterobacterales (CRE)\n* Multidrug-resistant Organisms (MRO)\n* Vancomycin-resistant Enterobacterales (VRE)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Antimicrobial-impregnated Central Venous Catheters (CVCs)', 'Central Line-associated Bloodstream Infection (CLABSI)', 'Intensive Care Unit (ICU)'], 'conditions': ['CLABSI - Central Line Associated Bloodstream Infection']}, 'referencesModule': {'references': [{'pmid': '29904809', 'type': 'RESULT', 'citation': 'Wang H, Tong H, Liu H, Wang Y, Wang R, Gao H, Yu P, Lv Y, Chen S, Wang G, Liu M, Li Y, Yu K, Wang C. Effectiveness of antimicrobial-coated central venous catheters for preventing catheter-related blood-stream infections with the implementation of bundles: a systematic review and network meta-analysis. Ann Intensive Care. 2018 Jun 15;8(1):71. doi: 10.1186/s13613-018-0416-4.'}, {'pmid': '26982376', 'type': 'RESULT', 'citation': "Lai NM, Chaiyakunapruk N, Lai NA, O'Riordan E, Pau WS, Saint S. Catheter impregnation, coating or bonding for reducing central venous catheter-related infections in adults. Cochrane Database Syst Rev. 2016 Mar 16;3(3):CD007878. doi: 10.1002/14651858.CD007878.pub3."}, {'pmid': '25278411', 'type': 'RESULT', 'citation': 'Lorente L, Lecuona M, Jimenez A, Lorenzo L, Diosdado S, Marca L, Mora ML. Cost/benefit analysis of chlorhexidine-silver sulfadiazine-impregnated venous catheters for femoral access. Am J Infect Control. 2014 Oct;42(10):1130-2. doi: 10.1016/j.ajic.2014.06.027.'}, {'pmid': '27378009', 'type': 'RESULT', 'citation': 'Lorente L, Lecuona M, Jimenez A, Cabrera J, Santacreu R, Lorenzo L, Raja L, Mora ML. Chlorhexidine-silver sulfadiazine-impregnated venous catheters are efficient even at subclavian sites without tracheostomy. Am J Infect Control. 2016 Dec 1;44(12):1526-1529. doi: 10.1016/j.ajic.2016.04.236. Epub 2016 Jul 1.'}, {'pmid': '24581021', 'type': 'RESULT', 'citation': 'Lorente L, Lecuona M, Jimenez A, Santacreu R, Raja L, Gonzalez O, Mora ML. Chlorhexidine-silver sulfadiazine-impregnated venous catheters save costs. Am J Infect Control. 2014 Mar;42(3):321-4. doi: 10.1016/j.ajic.2013.09.022.'}, {'pmid': '33901588', 'type': 'RESULT', 'citation': 'Rosenthal VD, Duszynska W, Ider BE, Gurskis V, Al-Ruzzieh MA, Myatra SN, Gupta D, Belkebir S, Upadhyay N, Zand F, Todi SK, Kharbanda M, Nair PK, Mishra S, Chaparro G, Mehta Y, Zala D, Janc J, Aguirre-Avalos G, Aguilar-De-Moros D, Hernandez-Chena BE, Gun E, Oztoprak-Cuvalci N, Yildizdas D, Abdelhalim MM, Ozturk-Deniz SS, Gan CS, Hung NV, Joudi H, Omar AA, Gikas A, El-Kholy AA, Barkat A, Koirala A, Cerero-Gudino A, Bouziri A, Gomez-Nieto K, Fisher D, Medeiros EA, Salgado-Yepez E, Horhat F, Agha HMM, Vimercati JC, Villanueva V, Jayatilleke K, Nguyet LTT, Raka L, Miranda-Novales MG, Petrov MM, Apisarnthanarak A, Tayyab N, Elahi N, Mejia N, Morfin-Otero R, Al-Khawaja S, Anguseva T, Gupta U, Belskii VA, Mat WRW, Chapeta-Parada EG, Guanche-Garcell H, Barahona-Guzman N, Mathew A, Raja K, Pattnaik SK, Pandya N, Poojary AA, Chawla R, Mahfouz T, Kanj SS, Mioljevic V, Hlinkova S, Mrazova M, Al-Abdely HM, Guclu E, Ozgultekin A, Baytas V, Tekin R, Yalcin AN, Erben N. International Nosocomial Infection Control Consortium (INICC) report, data summary of 45 countries for 2013-2018, Adult and Pediatric Units, Device-associated Module. Am J Infect Control. 2021 Oct;49(10):1267-1274. doi: 10.1016/j.ajic.2021.04.077. Epub 2021 Apr 24.'}]}, 'descriptionModule': {'briefSummary': "Central venous catheters (CVCs) are indispensable in modern critical care. However, CVC usage is associated with complications, including central line-associated bloodstream infections (CLABSIs), which in turn, is translated to higher healthcare costs and mortality.\n\nThe use of antimicrobial-impregnated CVCs is one of the strategies to reduce CLABSI.\n\nNevertheless, its' efficacy and beneficial effects, particularly in terms of patients' outcome had not been homogeneously demonstrated across literature. Moreover, antimicrobial-impregnated CVCs are more expensive compared to conventional non-impregnated ones, and hence its cost-effectiveness remains doubtful. To date, no local studies have been conducted to evaluate the efficacy and economic impact of antimicrobial-impregnated CVCs and on patients' outcome.\n\nThe goal of this clinical trial is to determine the efficacy and cost-effectiveness of antimicrobial-impregnated CVCs in preventing (CLABSI) among critically ill patients in a Malaysia University Hospital Adult Intensive Care Unit.\n\nThe main questions it aims to answer are:\n\n1. Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?\n2. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in Malaysia adult ICU affect patient length of stay when compared to non- impregnated CVCs?\n3. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?\n4. How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs?\n\nPatients who require a CVC for critical care in ICU will be recruited and randomly assigned to one of the two different groups to receive either a conventional non-impregnated CVC or an antimicrobial-impregnated CVC, which will be inserted and handled by medical practitioners. Participants will then be monitored for symptoms and signs of CLABSI, alongside length of ICU stay \\& healthcare costs. Researchers will compare CLABSI rates and other relevant parameters among the 2 groups to see if antimicrobial-impregnated CVCs are useful and cost-effective in CLABSI prevention.", 'detailedDescription': "Central venous catheters (CVCs) are indispensable in modern critical care. The average central line utilisation ratios in the ICUs across 45 countries were reported at 0.525.\n\nHowever, CVC usage is associated with complications, including central line-associated bloodstream infections (CLABSIs). The rate of CLABSI is reported at 4.45 per 1000 central line days in ICUs across 45 countries from 2013 - 2018. This in turn, is translated to higher healthcare costs and mortality.\n\nAntimicrobial-impregnated CVCs are proposed to be able to reduce the incidence of CLABSI by inhibiting microorganism colonisation on CVCs. A meta-analysis published in 2018 concluded that antimicrobial-impregnated CVCs were significantly effective in reducing CLABSIs and catheter colonisations.\n\nNevertheless, its' efficacy and beneficial effects, particularly in terms of patients' outcome had not been homogeneously demonstrated across literature. Moreover, antimicrobial-impregnated CVCs are more expensive compared to conventional non-impregnated ones, and hence its' cost-effectiveness remains doubtful. To date, no local studies have been conducted to evaluate the efficacy and economic impact of antimicrobial-impregnated CVCs and on patients' outcome.\n\nThe goal of this clinical trial is to determine the efficacy and cost-effectiveness of antimicrobial-impregnated CVCs in preventing (CLABSI) among critically ill patients in a Malaysia University Hospital Adult Intensive Care Unit.\n\nThe main questions it aims to answer are:\n\n1. Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?\n2. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in Malaysia adult ICU affect patient length of stay when compared to non-impregnated CVCs?\n3. Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?\n4. How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs?\n\nThe primary and secondary objectives of the study include the following:\n\n\\- Primary objective: To compare the incidence of CLABSI rate in patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU\n\n\\- Secondary objectives:\n\n1. To determine the length of stay of patients using antimicrobial-impregnated CVCs vs non-impregnated CVCs in Malaysia adult ICU\n2. To undertake a cost-effectiveness analysis in prevention of CLABSI between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU\n3. To compare the antimicrobial resistance features of the bacterial species that caused CLABSI between patients using antimicrobial-impregnated CVCs and that of non-impregnated CVCs in Malaysia adult ICU The study will be conducted in the adult Intensive Care Unit (ICU) of Universiti Malaya Medical Centre (UMMC), Malaysia, which is a mixed medical/surgical ICU, over a period of 1 year.\n\nPatients who require a CVC for critical care in ICU will be recruited and randomly assigned to one of the two different groups to receive either a conventional non-impregnated CVC or an antimicrobial-impregnated CVC, which will be inserted and handled by medical practitioners. Participants will then be monitored for symptoms and signs of CLABSI, alongside length of ICU stay \\& healthcare costs. The diagnosis of CLABSI will be based on the CDC-NHSN (Centers for Disease Control and Prevention - National Healthcare Safety Network) definition. Researchers will then analyse and compare CLABSI rates and other relevant parameters among the 2 groups to see if antimicrobial-impregnated CVCs are useful and cost-effective in CLABSI prevention. Descriptive statistics will be expressed as percentages unless otherwise stated. Categorical variables will be expressed as percentages and compared using the Chi-square or Fisher's exact test, whichever is appropriate. Variables with a univariate test value of less than 0.05 (p-value) will be included in a multivariate analysis using a logistic regression model. Odds ratios (OR) and 95% confidence intervals (CI) will be calculated to identify the risk factors associated with the development of CLABSI in patients. In all instances, a p-value of less than or equal to 0.05 will be considered significant.\n\nLocal data at ICU, UMMC reported the incidence of CLABSI per 1000 catheter days in the first 6 months of 2022, to be 12.18. Using SAS (Statistical Analysis Software)® for sample size calculation, in order to detect a clinically significant reduction of CLABSI by 30%, and assuming a two-sided type I error protection of 0.05 and a power of 0.80, the calculated required sample size is 50 patients. To incorporate a 10% drop out rate, the study therefore aims to recruit 55 patients in each arm, making up to a total sample size of 110.\n\nAll data \\& information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations.\n\nThe study hopes to demonstrate that the usage of antimicrobial-impregnated CVCs among adult critically ill patient in the ICU can reduce CLABSIs and this will translate to reduced patients' length of stay and healthcare costs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years old and above who are admitted to the ICU of UMMC during the study period\n* Patients who require a CVC during ICU stay\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study\n* Patients with known hypersensitivity reaction to CVC materials\n* Patients with pre-existing diagnosis of CLABSI upon admission to the ICU\n* Patients with pre-existing bloodstream infection upon admission to the ICU\n* Patients with a pre-existing CVC, where sterility during placement may be compromised (e.g. in an emergency situation)\n* Patients with indwelling CVC less than 48 hours\n* Patients who had poor compliance to catheter bundle care during CVC handling throughout the indwelling catheter period\n* Patients who require \\> 1 CVC or other central venous access'}, 'identificationModule': {'nctId': 'NCT05959018', 'briefTitle': 'Efficacy & Cost Effectiveness of Antimicrobial-impregnated CVCs in CLABSI Prevention in a Malaysia Adult ICU', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Efficacy & Health Economics of Antimicrobial-impregnated Central Venous Catheters (CVCs) Compared to Non-impregnated CVCs in Central Line-associated Bloodstream Infection Prevention in a Malaysia University Hospital Adult ICU', 'orgStudyIdInfo': {'id': 'UM-AMCVC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter', 'description': 'Control group who receives non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter', 'interventionNames': ['Device: Arrow Three-Lumen Central Venous Catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter', 'description': 'Group who receives antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter', 'interventionNames': ['Device: Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter']}], 'interventions': [{'name': 'Arrow Three-Lumen Central Venous Catheter', 'type': 'DEVICE', 'description': 'Participants in the Non-impregnated CVC arm will receive Arrow Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use', 'armGroupLabels': ['Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter']}, {'name': 'Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter', 'type': 'DEVICE', 'description': 'Participants in the Antimicrobial-impregnated CVC arm will receive Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use', 'armGroupLabels': ['Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Kai Ming Tan', 'role': 'CONTACT', 'email': 'kaiming.pg91@gmail.com', 'phone': '+60174787668'}], 'facility': 'Universiti of Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Kai Ming Tan', 'role': 'CONTACT', 'email': 'kaiming.pg91@gmail.com', 'phone': '+60174787668'}, {'name': 'Ina Ismiarti Shariffuddin', 'role': 'CONTACT', 'email': 'ismiarti@ummc.edu.my', 'phone': '+60379492052'}], 'overallOfficials': [{'name': 'Kai Ming Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teleflex', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator/ Postgraduate Student', 'investigatorFullName': 'Tan Kai Ming', 'investigatorAffiliation': 'University of Malaya'}}}}