CLABSI - Central Line Associated Bloodstream InfectionNCT05959018
Efficacy & Cost Effectiveness of Antimicrobial-impregnated CVCs in CLABSI Prevention in a Malaysia Adult ICU
A study testing Arrow Three-Lumen Central Venous Catheter and Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter in people with CLABSI - Central Line Associated Bloodstream Infection, run by University of Malaya at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- CLABSI - Central Line Associated Bloodstream Infection
- What is being tested?
- Arrow Three-Lumen Central Venous Catheter and Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Jan 2024to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years old and above who are admitted to the ICU of UMMC during the study period
- Patients who require a CVC during ICU stay
Who cannot join
- Patients who refuse to participate in the study
- Patients with known hypersensitivity reaction to CVC materials
- Patients with pre-existing diagnosis of CLABSI upon admission to the ICU
- Patients with pre-existing bloodstream infection upon admission to the ICU
- Patients with a pre-existing CVC, where sterility during placement may be compromised (e.g. in an emergency situation)
- Patients with indwelling CVC less than 48 hours
- Patients who had poor compliance to catheter bundle care during CVC handling throughout the indwelling catheter period
- Patients who require > 1 CVC or other central venous access
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: 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
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.
The use of antimicrobial-impregnated CVCs is one of the strategies to reduce CLABSI.
Read more
Nevertheless, 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.
The 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.
The main questions it aims to answer are:
- Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?
- 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?
- Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?
- How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs?
Patients 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.
Read the detailed description
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.
However, 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.
Antimicrobial-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.
Nevertheless, 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.
The 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.
The main questions it aims to answer are:
- Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?
- 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?
- Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?
- How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs?
The primary and secondary objectives of the study include the following:
- Primary objective: To compare the incidence of CLABSI rate in patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU
- Secondary objectives:
- To determine the length of stay of patients using antimicrobial-impregnated CVCs vs non-impregnated CVCs in Malaysia adult ICU
- To undertake a cost-effectiveness analysis in prevention of CLABSI between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU
- 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.
Patients 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.
Local 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.
All data \& information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations.
The 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.
- Being tested
- Arrow Three-Lumen Central Venous Catheter, Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter
- Keywords
- Antimicrobial-impregnated Central Venous Catheters (CVCs), Central Line-associated Bloodstream Infection (CLABSI), Intensive Care Unit (ICU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrow Three-Lumen Central Venous CatheterDevice
Participants in the Non-impregnated CVC arm will receive Arrow Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use
Arrowg+ard Blue Plus® Three-Lumen Central Venous CatheterDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter | Sham comparator | Control group who receives non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter Receives: Device: Arrow Three-Lumen Central Venous Catheter |
| Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter | Experimental | Group who receives antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter Receives: Device: Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central line-associated bloodstream infection (CLABSI) rate
CLABSI cases per 1000 catheter days
Measured: Through study completion, tentatively up to 1 year
Secondary outcomes (4)
ICU Length of stay of patients diagnosed with CLABSI
Days of ICU stay
Measured: Through study completion, tentatively up to 1 year
Healthcare costs of patients diagnosed with CLABSI
Healthcare costs, expressed in Malaysian Ringgit (MYR)
Measured: Through study completion, tentatively up to 1 year
Percentages of specific bacterial species isolated from patients diagnosed with CLABSI
Percentages of specific bacterial species isolated from patients diagnosed with CLABSI
Examples:
- Gram positive organisms: Coagulase negative Staphylococci (CONS), Enterococci, Staphylococcus aureus
- Gram negative organisms: Klebsiella, Pseudomonas, Escherichia coli, Acinetobacter
Measured: Through study completion, tentatively up to 1 year
Percentages of antimicrobial resistance pattern groups among bacterial species isolated from patients diagnosed with CLABSI
Percentages of antimicrobial resistance pattern groups among bacterial species isolated from patients diagnosed with CLABSI
Examples:
- Methicillin Resistant Staphylococcus aureus (MRSA)
- Extended-spectrum beta-lactamase (ESBL) producing Enterobacterales
- Carbapenam-resistant Enterobacterales (CRE)
- Multidrug-resistant Organisms (MRO)
- Vancomycin-resistant Enterobacterales (VRE)
Measured: Through study completion, tentatively up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start19 Jan 2024
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CLABSI - Central Line Associated Bloodstream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Teleflex
- Responsible party
- Principal investigator, Tan Kai Ming, University of Malaya
- Investigators
- Kai Ming Tan, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959018
- Sponsor's protocol ID
- UM-AMCVC-01
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29904809Lai 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.
PubMed 26982376Lorente 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.
PubMed 25278411Lorente 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.
PubMed 27378009Lorente 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.
PubMed 24581021Rosenthal 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.
PubMed 33901588
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05959018
- Acronym / sponsor ID
- UM-AMCVC-01
- Keywords
- Antimicrobial-impregnated Central Venous Catheters (CVCs), Central Line-associated Bloodstream Infection (CLABSI), Intensive Care Unit (ICU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Teleflex
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The use of antimicrobial-impregnated CVCs is one of the strategies to reduce CLABSI.
Nevertheless, 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.
The 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.
The main questions it aims to answer are:
- Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?
- 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?
- Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?
- How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs?
Patients 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.
Detailed description
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.
However, 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.
Antimicrobial-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.
Nevertheless, 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.
The 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.
The main questions it aims to answer are:
- Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?
- 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?
- Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?
- How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs?
The primary and secondary objectives of the study include the following:
- Primary objective: To compare the incidence of CLABSI rate in patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU
- Secondary objectives:
- To determine the length of stay of patients using antimicrobial-impregnated CVCs vs non-impregnated CVCs in Malaysia adult ICU
- To undertake a cost-effectiveness analysis in prevention of CLABSI between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU
- 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.
Patients 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.
Local 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.
All data \& information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations.
The 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter | Sham comparator | Device: Arrow Three-Lumen Central Venous CatheterControl group who receives non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter |
| Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter | Experimental | Device: Arrowg+ard Blue Plus® Three-Lumen Central Venous CatheterGroup who receives antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years old and above who are admitted to the ICU of UMMC during the study period
- Patients who require a CVC during ICU stay
Key exclusion criteria (8 listed)
- Patients who refuse to participate in the study
- Patients with known hypersensitivity reaction to CVC materials
- Patients with pre-existing diagnosis of CLABSI upon admission to the ICU
- Patients with pre-existing bloodstream infection upon admission to the ICU
- Patients with a pre-existing CVC, where sterility during placement may be compromised (e.g. in an emergency situation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arrow Three-Lumen Central Venous CatheterParticipants in the Non-impregnated CVC arm will receive Arrow Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use | Device | Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter |
| Arrowg+ard Blue Plus® Three-Lumen Central Venous CatheterParticipants 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 | Device | Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter |
Primary outcome
Central line-associated bloodstream infection (CLABSI) rate
Time frame: Through study completion, tentatively up to 1 year
CLABSI cases per 1000 catheter days
4 secondary outcomes
ICU Length of stay of patients diagnosed with CLABSI
Time frame: Through study completion, tentatively up to 1 year
Healthcare costs of patients diagnosed with CLABSI
Time frame: Through study completion, tentatively up to 1 year
Percentages of specific bacterial species isolated from patients diagnosed with CLABSI
Time frame: Through study completion, tentatively up to 1 year
Percentages of antimicrobial resistance pattern groups among bacterial species isolated from patients diagnosed with CLABSI
Time frame: Through study completion, tentatively up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 29904809Wang 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.
- Results publication: PubMed 26982376Lai 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.
- Results publication: PubMed 25278411Lorente 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.
- Results publication: PubMed 27378009Lorente 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.
- Results publication: PubMed 24581021Lorente 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.
- Results publication: PubMed 33901588Rosenthal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Ming Tan principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arrow Three-Lumen Central Venous Catheter and Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter in people with CLABSI - Central Line Associated Bloodstream Infection, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central line-associated bloodstream infection (CLABSI) rate (time frame: Through study completion, tentatively up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959018, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.