BacteriuriaNCT04461262
The Impact Of A Catheter Coating On Clinical Bacteriuria
A study testing Camstent Coated Catheter in people with Bacteriuria, run by Camstent Ltd. at 4 sites in United Kingdom.
Trial summary
A prospective multicentre randomized study to assess the impact of a catheter coating on clinical bacteriuria when compared to an uncoated foley catheter. Each participant will take part in the trial from the time the participant signs the informed consent form (ICF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteriuria
- What is being tested?
- Camstent Coated Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 27 Apr 2021to Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines
- Patients aged 18+ years will be eligible for the study.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Who cannot join
- Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
- Pregnant or Breastfeeding.
- Patients with a potentially immunocompromised conditions (HIV)
- Has a known silicone allergy or sensitivity
- Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
- Any medication deemed by the Investigator to potentially interfere with the study treatment
- Participation in any other clinical study.
- Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
Stoke Mandeville Hospital
Buckingham
Maurizo Belci
- Recruiting
Addenbrookes Hospital
Cambridge
Suzanne Biers
- Recruiting
Royal National Orthopaedic Hospital
London
- Recruiting
Norfolk & Norwich University Hospital
Norwich
Mark Rochester
About this study
Official title: A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria
A prospective multicentre randomized study to assess the impact of a catheter coating on clinical bacteriuria when compared to an uncoated foley catheter.
Each participant will take part in the trial from the time the participant signs the informed consent form (ICF).
Read more
After the screening visit, the participants will be randomized to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed as per standard hospital guidelines, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent.
During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.
- Conditions
- Bacteriuria
- Being tested
- Camstent Coated Catheter, Standard Care
- Medical subject headings
- Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camstent Coated CatheterDevice
Also called Standard Care
The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked
Standard CareDevice
Uncoated Foley catheter
| Study group | Role | What they receive |
|---|---|---|
| Camstent Coated Catheter | Experimental | The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked Receives: Device: Camstent Coated Catheter |
| Standard Care | Other | Foley catheter, uncoated Receives: Device: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of days in which bacterial concentrations are greater than 10^5 CFU/mL in coated catheters, as compared to uncoated control catheters
Measured: 1 Year
Secondary outcomes (3)
Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
Measured: 1 Year
Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
Measured: 1 Year
Patient Reported Outcomes (PRO)
EQ-5D-5L questionnaire will be given to participants as well as a questionnaire asking participants on their experience using the catheter
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start27 Apr 2021
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteriuriaStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Camstent Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prital Patel, Study director, Camstent Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461262
- Sponsor's protocol ID
- Cam-Cath-001
- Status last verified
- Dec 2022
- First submitted
- 1 Jul 2020
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria
- ClinicalTrials.gov ID
- NCT04461262
- Acronym / sponsor ID
- Cam-Cath-001
- Conditions
- Bacteriuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Camstent Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 8 Jul 2020 (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.
A prospective multicentre randomized study to assess the impact of a catheter coating on clinical bacteriuria when compared to an uncoated foley catheter.
Each participant will take part in the trial from the time the participant signs the informed consent form (ICF).
After the screening visit, the participants will be randomized to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed as per standard hospital guidelines, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent.
During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camstent Coated Catheter | Experimental | Device: Camstent Coated CatheterThe patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked |
| Standard Care | Other | Device: Standard CareFoley catheter, uncoated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines
- Patients aged 18+ years will be eligible for the study.
- Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Key exclusion criteria (8 listed)
- Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
- Pregnant or Breastfeeding.
- Patients with a potentially immunocompromised conditions (HIV)
- Has a known silicone allergy or sensitivity
- Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
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 |
|---|---|---|
| Camstent Coated CatheterAlso: Standard CareThe patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked | Device | Camstent Coated Catheter |
| Standard CareUncoated Foley catheter | Device | Standard Care |
Primary outcome
Change in the number of days in which bacterial concentrations are greater than 10^5 CFU/mL in coated catheters, as compared to uncoated control catheters
Time frame: 1 Year
3 secondary outcomes
Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
Time frame: 1 Year
Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
Time frame: 1 Year
Patient Reported Outcomes (PRO)
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- CamstentLink provided by the sponsor.
- 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.
Prital Patel study director
Camstent Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camstent Coated Catheter in people with Bacteriuria, run by Camstent Ltd. at 4 sites in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prital Patel (+447825757008, prital.patel@camstent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of days in which bacterial concentrations are greater than 10^5 CFU/mL in coated catheters, as compared to uncoated control catheters (time frame: 1 Year). 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 28 Dec 2022.