SepsisPhase 4NCT06804798
Evaluation of Catheter Associated Urinary Tract Infection Between Metal Alloy Coated Catheter and Conventional Latex Catheter in Critically Ill Patients
A Phase 4 study testing Latex metal alloy coated catheter and conventional latex urinary catheter in people with Sepsis and Urosepsis, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This is a prospective single blinded randomized trial to evaluate the incidence of catheter associated urinary tract infection (CAUTI) between latex catheter and metal alloy coated catheter among Intensive Care Unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Urosepsis, Intensive Care Unit
- What is being tested?
- Latex metal alloy coated catheter and conventional latex urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2023to 1 Nov 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult more than 18 years old
- Indwelling urinary catheter more than 48 hours Exclusion Criteria
- 1. Community urosepsis 2. Chronic kidney disease and end stage renal failure 3. Suprapubic catheter 4. Patient with dependent urinary catheter 5. Pregnant ladies 6. Congenital urinary tract abnormality 7. Surgical procedure involving urinary tract 8. Moribound patient or expected to die within 24 hours 9. Discharged to ward within 48 hours 10. Latex allergy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, 56000
About this study
This is a prospective single blinded randomized trial to evaluate the incidence of catheter associated urinary tract infection (CAUTI) between latex catheter and metal alloy coated catheter among Intensive Care Unit (ICU) patients. CAUTI has a few definitions, in this study, we will follow the latest Central of Disease Control (CDC) guideline definition of CAUTI in January 2022.
This study involves 100 patients who meet the inclusion and exclusion criteria that have been set. The patients will be divided into group A and group B and two types of catheters will be given out to the healthcare workers according to the randomization. Data collection involves demographic, medical and laboratory data and will be documented in the tables provided. All data will be collected from day of urinary catheterization in ICU until patients discharge or die or maximum of 14 days in ICU or develop CAUTI or ABUTI or whichever that occurred earlier. Patients who died within 48 hours of catheter insertion, will be considered as drop-out.
Data that has been extrapolated from this study will then give us an insight regarding the best type of catheter to avoid CAUTI, risk factors associated with CAUTI and to determine length of ICU stay and ICU morbidity with patients who have CAUTI. This study proves to be important in reducing the overall healthcare associated infection in the ICU setting.
- Conditions
- Sepsis, Urosepsis, Intensive Care Unit
- Being tested
- Latex metal alloy coated catheter, conventional latex urinary catheter
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latex metal alloy coated catheterDevice
Metal alloy works as an antiseptic whereby preventing the attachment of biofilm to the catheter lining.
conventional latex urinary catheterDevice
Latex catheters prove to be soft, flexible, inexpensive and thermo-sensitive towards body temperature. However, there is a risk of developing CAUTI as bacteria are more susceptible to adhere to latex.
| Study group | Role | What they receive |
|---|---|---|
| Conventional latex urinary catheter | Active comparator | Not described Receives: Device: Latex metal alloy coated catheter |
| Latex metal alloy coated catheter | Experimental | Not described Receives: Device: conventional latex urinary catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare
To compare catheter associated urinary tract infections rate between conventional latex urinary catheter and latex metal alloy
Measured: 2 years
Secondary outcomes (5)
To compare
To compare the rate of bacteremia from catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Measured: 2 years
To compare
To compare the common types of microorganisms associated with catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Measured: 2 years
To compare
To compare risk factor that is associated with catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Measured: 2 years
To compare
To compare the incidence of acute kidney injury (AKI) in catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Measured: 2 years
Length of stay
To determine length of stay in ICU and ICU mortality in catheter associated urinary tract infection between conventional latex urinary catheter and latex metal alloy catheter
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Mar 2023
- Primary completion1 Jul 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study is between urinary catheter and conventional latex urinary catheter and metal alloy coated urinary catheter
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Nizam Mokhtar, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804798
- Sponsor's protocol ID
- FF-2023-056
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Catheter Associated Urinary Tract Infection Between Metal Alloy Coated Catheter and Conventional Latex Catheter in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06804798
- Acronym / sponsor ID
- FF-2023-056
- Conditions
- Sepsis, Urosepsis, Intensive Care Unit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 3 Feb 2025 (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.
This is a prospective single blinded randomized trial to evaluate the incidence of catheter associated urinary tract infection (CAUTI) between latex catheter and metal alloy coated catheter among Intensive Care Unit (ICU) patients. CAUTI has a few definitions, in this study, we will follow the latest Central of Disease Control (CDC) guideline definition of CAUTI in January 2022.
This study involves 100 patients who meet the inclusion and exclusion criteria that have been set. The patients will be divided into group A and group B and two types of catheters will be given out to the healthcare workers according to the randomization. Data collection involves demographic, medical and laboratory data and will be documented in the tables provided. All data will be collected from day of urinary catheterization in ICU until patients discharge or die or maximum of 14 days in ICU or develop CAUTI or ABUTI or whichever that occurred earlier. Patients who died within 48 hours of catheter insertion, will be considered as drop-out.
Data that has been extrapolated from this study will then give us an insight regarding the best type of catheter to avoid CAUTI, risk factors associated with CAUTI and to determine length of ICU stay and ICU morbidity with patients who have CAUTI. This study proves to be important in reducing the overall healthcare associated infection in the ICU setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The interventional study is between urinary catheter and conventional latex urinary catheter and metal alloy coated urinary catheter
| Arm | Type | Receives |
|---|---|---|
| Conventional latex urinary catheter | Active comparator | Device: Latex metal alloy coated catheter |
| Latex metal alloy coated catheter | Experimental | Device: conventional latex urinary catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult more than 18 years old
- Indwelling urinary catheter more than 48 hours Exclusion Criteria
- 1. Community urosepsis 2. Chronic kidney disease and end stage renal failure 3. Suprapubic catheter 4. Patient with dependent urinary catheter 5. Pregnant ladies 6. Congenital urinary tract abnormality 7. Surgical procedure involving urinary tract 8. Moribound patient or expected to die within 24 hours 9. Discharged to ward within 48 hours 10. Latex allergy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Latex metal alloy coated catheterMetal alloy works as an antiseptic whereby preventing the attachment of biofilm to the catheter lining. | Device | Conventional latex urinary catheter |
| conventional latex urinary catheterLatex catheters prove to be soft, flexible, inexpensive and thermo-sensitive towards body temperature. However, there is a risk of developing CAUTI as bacteria are more susceptible to adhere to latex. | Device | Latex metal alloy coated catheter |
Primary outcome
To Compare
Time frame: 2 years
To compare catheter associated urinary tract infections rate between conventional latex urinary catheter and latex metal alloy
5 secondary outcomes
To compare
Time frame: 2 years
To compare
Time frame: 2 years
To compare
Time frame: 2 years
To compare
Time frame: 2 years
Length of stay
Time frame: 2 years
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 3 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Latex metal alloy coated catheter and conventional latex urinary catheter in people with Sepsis and Urosepsis, run by National University of Malaysia 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 3 inclusion and 0 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 3 Feb 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To Compare (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.