Efficacy & Cost Effectiveness of Antimicrobial-impregnated CVCs in CLABSI Prevention in a Malaysia Adult ICU
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ClinicalTrials.gov Identifier: NCT05959018 |
Recruitment Status :
Recruiting
First Posted : July 25, 2023
Last Update Posted : March 25, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
CLABSI - Central Line Associated Bloodstream Infection | Device: Arrow Three-Lumen Central Venous Catheter Device: Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomised Controlled Trial |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | January 19, 2024 |
Estimated Primary Completion Date : | April 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Sham Comparator: Non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter
Control group who receives non-impregnated CVC - Arrow Three-Lumen Central Venous Catheter
|
Device: Arrow Three-Lumen Central Venous Catheter
Participants in the Non-impregnated CVC arm will receive Arrow Three-Lumen Central Venous Catheter inserted by healthcare personnel for critical care use |
Experimental: Antimicrobial-impregnated CVC - Arrowg+ard Blue Plus® Three-Lumen Central Venous Catheter
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
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 |
- Central line-associated bloodstream infection (CLABSI) rate [ Time Frame: Through study completion, tentatively up to 1 year ]CLABSI cases per 1000 catheter days
- ICU Length of stay of patients diagnosed with CLABSI [ Time Frame: Through study completion, tentatively up to 1 year ]Days of ICU stay
- Healthcare costs of patients diagnosed with CLABSI [ Time Frame: Through study completion, tentatively up to 1 year ]Healthcare costs, expressed in Malaysian Ringgit (MYR)
- Percentages of specific bacterial species isolated from 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
Examples:
- Gram positive organisms: Coagulase negative Staphylococci (CONS), Enterococci, Staphylococcus aureus
- Gram negative organisms: Klebsiella, Pseudomonas, Escherichia coli, Acinetobacter
- 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 ]
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)
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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959018
Contact: Kai Ming Tan | +60174787668 | kaiming.pg91@gmail.com | |
Contact: Ina Ismiarti Shariffuddin | +60379492052 | ismiarti@ummc.edu.my |
Malaysia | |
Universiti of Malaya Medical Centre | Recruiting |
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100 | |
Contact: Kai Ming Tan +60174787668 kaiming.pg91@gmail.com |
Principal Investigator: | Kai Ming Tan | University of Malaya |
Documents provided by Tan Kai Ming, University of Malaya:
Responsible Party: | Tan Kai Ming, Principal Investigator/ Postgraduate Student, University of Malaya |
ClinicalTrials.gov Identifier: | NCT05959018 |
Other Study ID Numbers: |
UM-AMCVC-01 |
First Posted: | July 25, 2023 Key Record Dates |
Last Update Posted: | March 25, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Antimicrobial-impregnated Central Venous Catheters (CVCs) Central Line-associated Bloodstream Infection (CLABSI) Intensive Care Unit (ICU) |
Infections Sepsis Pathologic Processes Systemic Inflammatory Response Syndrome Inflammation |