Efficacy & Cost Effectiveness of Antimicrobial-impregnated CVCs in CLABSI Prevention in a Malaysia Adult ICU

NCT05959018 | Completed FDA Device

• 1 other identifier: UM-AMCVC-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Is there any difference in CLABSI rates between patients using antimicrobial-impregnated CVCs and non-impregnated CVCs in Malaysia adult ICU?
2. 2.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?
3. 3.Does the use of antimicrobial-impregnated CVCs in CLABSI prevention in the adult ICU setting affect healthcare costs when compared to non-impregnated CVCs?
4. 4.How antimicrobial resistance features of the bacteria causing CLABSI may differ in patients using antimicrobial-impregnated CVCs compared to non-impregnated CVCs?

Conditions

CLABSI - Central Line Associated Bloodstream Infection

Keywords

Antimicrobial-impregnated Central Venous Catheters (CVCs); Central Line-associated Bloodstream Infection (CLABSI); Intensive Care Unit (ICU)

Outcome Measures

Primary Outcomes (1)

• Central line-associated bloodstream infection (CLABSI) rate

  CLABSI cases per 1000 catheter days

  Through study completion, tentatively up to 1 year

Secondary Outcomes (4)

• ICU Length of stay of patients diagnosed with CLABSI

  Through study completion, tentatively up to 1 year

• Healthcare costs of patients diagnosed with CLABSI

  Through study completion, tentatively up to 1 year

• Percentages of specific bacterial species isolated from patients diagnosed with CLABSI

  Through study completion, tentatively up to 1 year

• Percentages of antimicrobial resistance pattern groups among bacterial species isolated from patients diagnosed with CLABSI

  Through study completion, tentatively up to 1 year

Study Arms (2)

Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter

SHAM COMPARATOR

Control group who receives non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter

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

Device: Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter

Interventions

Arrow Three-Lumen Central Venous Catheter DEVICE

Participants in the Non-impregnated CVC arm will receive Arrow Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use

Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter

Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter DEVICE

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

Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• Teleflex: collaborator

Study Sites (1)

Universiti of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (6)

• 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: 29904809 RESULT

• 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: 26982376 RESULT

• 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: 25278411 RESULT

• 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: 27378009 RESULT

• 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: 24581021 RESULT

• 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.

  PMID: 33901588 RESULT

Study Officials

• Kai Ming Tan

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/ Postgraduate Student

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 25, 2023
• Study Start: January 19, 2024
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)