Urinary Tract InfectionsNCT04825314
Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization
A study testing Urethral catheter in people with Urinary Tract Infections and Catheter Infection, run by Alexandria University at 1 site in Egypt.
Trial summary
Eighty percent of nosocomial UTI caused by indwelling urinary catheters and so known-as catheter-associated UTI. CAUTI leads to multiple local and systemic derangements such as suprapubic pain, dysuria, cystitis, pyelonephritis, septicemia, and even septic shock. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Tract Infections, Catheter Infection, Catheter-Related Infections
- What is being tested?
- Urethral catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2020to 21 Jun 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient under age of 80 years old who need prolonged urethral catheterization (more than 2 weeks) as a method of bladder drainage.
Who cannot join
- Patients with current or recent symptomatic urinary tract infection.
- Antibiotic use currently or within 7 days prior to inclusion.
- Known hypersensitivity to latex, silver salts or hydrogel.
- Patients with recent surgical intervention in the urinary tract.
- Patients with anatomic or functional upper urinary tract issues (e.g reflux, stones, etc.)
- Uncontrolled DM. Patients on corticosteroid treatment. Immunosuppressed patients. Patients received pelvic irradiation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University Hospitals
Alexandria, 21646
Alaa Abdel Hady, MBBCH, +201223641864, medical_alaa@yahoo.com
Tamer A Abou Youssif, MD, +201101200076, tamer.abouyoussif@alexmed.edu.eg
About this study
Official title: Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study
Eighty percent of nosocomial UTI caused by indwelling urinary catheters and so known-as catheter-associated UTI. CAUTI leads to multiple local and systemic derangements such as suprapubic pain, dysuria, cystitis, pyelonephritis, septicemia, and even septic shock.
This study will be conducted up on 100 patients (50 per each group) with long term catheterization to assess efficacy of noble metal alloy coated catheter in reducing CAUTI.
Read the detailed description
This prospective controlled randomized study conducted upon 100 patients at Alexandria University hospital from 21 May 2020 to 21 December 2020. Patients enrolled will be divided into two equal groups according to the urethral catheter inserted
The institutional ethics committee for research approved the study. Written informed consent was obtained from all participants. In addition to taking the patients' medical history and completing general and physical examinations, physicians will choose proper catheter size all perform catheterization using aseptic technique according to guidelines of proper aseptic catheterization. Urologist ensures comparable catheter size and amount of balloon inflation.
An aseptic non-touch technique (ANTT) must be used to obtain catheter specimen urine following these steps:
- After catheterization apply clamp 10 cm distal to meatus then after few minutes clean the drainage port with alcohol and allow to dry then insert the syringe tip into the drainage port.
- Three to five ml of urine collected in sterile disposable plastic cup at day zero (within 2 hours of catheterization), day ten and day twenty post catheterization.
- The urine subjected to routine urine analysis, urine culture and sensitivity.
Appropriate statistical tests will be used to indicate the frequency and type of CAUTI as well as to assess catheter tolerance in each arm, followed by a comparison to conclude the results.
- Being tested
- Urethral catheter
- Keywords
- catheter, UTI, Foley catheter, Nobel Metal Alloy catheter
- Medical subject headings
- Urinary Tract Infections, Catheter-Related Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urethral catheterDevice
All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.
| Study group | Role | What they receive |
|---|---|---|
| Bactiguard urethral catheter | Active comparator | Group A: Fifty Patients with urethral catheter using noble metal alloy coated catheter (Bactiguard AB, Stockholm ,Sweden). Receives: Device: Urethral catheter |
| Silicone Foley urethral catheter | Active comparator | Group B: Fifty Patients with urethral catheter using silicone Foley catheter (Well Lead, Guangzhou, China). Receives: Device: Urethral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infection
incidence of culture documented symotomatic urinary tract infection
Measured: 14 days
Secondary outcomes (1)
Catheter tolerance
Catheter tolerance looks for discomfort or pain. Discomfort is an uncomfortable sensation due to the presence of a foreign object in the urethra without pain. The presence of actual pain is measured using VAS scoring system from zero to ten, so that a zero means no pain and a tenth means very severe pain.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start21 May 2020
- Primary completion21 May 2021 (estimated)
- Study completion21 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abou Youssif, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825314
- Sponsor's protocol ID
- 0106462
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aljohi AA, Hassan HE, Gupta RK. The efficacy of noble metal alloy urinary catheters in reducing catheter-associated urinary tract infection. Urol Ann. 2016 Oct-Dec;8(4):423-429. doi: 10.4103/0974-7796.192099.
PubMed 28057985
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04825314
- Acronym / sponsor ID
- 0106462
- Keywords
- catheter, UTI, Foley catheter, Nobel Metal Alloy catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 21 May 2021 (estimated)
- Study completion
- 21 Jun 2021 (estimated)
- First posted
- 1 Apr 2021 (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.
Eighty percent of nosocomial UTI caused by indwelling urinary catheters and so known-as catheter-associated UTI. CAUTI leads to multiple local and systemic derangements such as suprapubic pain, dysuria, cystitis, pyelonephritis, septicemia, and even septic shock.
This study will be conducted up on 100 patients (50 per each group) with long term catheterization to assess efficacy of noble metal alloy coated catheter in reducing CAUTI.
Detailed description
This prospective controlled randomized study conducted upon 100 patients at Alexandria University hospital from 21 May 2020 to 21 December 2020. Patients enrolled will be divided into two equal groups according to the urethral catheter inserted
The institutional ethics committee for research approved the study. Written informed consent was obtained from all participants. In addition to taking the patients' medical history and completing general and physical examinations, physicians will choose proper catheter size all perform catheterization using aseptic technique according to guidelines of proper aseptic catheterization. Urologist ensures comparable catheter size and amount of balloon inflation.
An aseptic non-touch technique (ANTT) must be used to obtain catheter specimen urine following these steps:
- After catheterization apply clamp 10 cm distal to meatus then after few minutes clean the drainage port with alcohol and allow to dry then insert the syringe tip into the drainage port.
- Three to five ml of urine collected in sterile disposable plastic cup at day zero (within 2 hours of catheterization), day ten and day twenty post catheterization.
- The urine subjected to routine urine analysis, urine culture and sensitivity.
Appropriate statistical tests will be used to indicate the frequency and type of CAUTI as well as to assess catheter tolerance in each arm, followed by a comparison to conclude the results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bactiguard urethral catheter | Active comparator | Device: Urethral catheterGroup A: Fifty Patients with urethral catheter using noble metal alloy coated catheter (Bactiguard AB, Stockholm ,Sweden). |
| Silicone Foley urethral catheter | Active comparator | Device: Urethral catheterGroup B: Fifty Patients with urethral catheter using silicone Foley catheter (Well Lead, Guangzhou, China). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient under age of 80 years old who need prolonged urethral catheterization (more than 2 weeks) as a method of bladder drainage.
Key exclusion criteria (6 listed)
- Patients with current or recent symptomatic urinary tract infection.
- Antibiotic use currently or within 7 days prior to inclusion.
- Known hypersensitivity to latex, silver salts or hydrogel.
- Patients with recent surgical intervention in the urinary tract.
- Patients with anatomic or functional upper urinary tract issues (e.g reflux, stones, etc.)
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 |
|---|---|---|
| Urethral catheterAll Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter. | Device | Bactiguard urethral catheter, Silicone Foley urethral catheter |
Primary outcome
Urinary tract infection
Time frame: 14 days
incidence of culture documented symotomatic urinary tract infection
1 secondary outcome
Catheter tolerance
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 28057985Aljohi AA, Hassan HE, Gupta RK. The efficacy of noble metal alloy urinary catheters in reducing catheter-associated urinary tract infection. Urol Ann. 2016 Oct-Dec;8(4):423-429. doi: 10.4103/0974-7796.192099.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urethral catheter in people with Urinary Tract Infections and Catheter Infection, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 6 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 8 Apr 2021. 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 Egypt. 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 Tamer A Abou Youssif, MD (+201101200076, tamer.abouyoussif@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infection (time frame: 14 days). 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 NCT04825314, which also lists 1 linked publication.
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 8 Apr 2021.