Catheter Associated Urinary Tract InfectionNCT01963013
Non-returning Catheter Valve for Reducing CAUTI
A study testing Non-returning catheter valve and Conventional urine bag in people with Catheter Associated Urinary Tract Infection and Critically Ill Patients, run by Khon Kaen University at 1 site in Thailand.
Trial summary
This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Associated Urinary Tract Infection, Critically Ill Patients
- What is being tested?
- Non-returning catheter valve and Conventional urine bag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Apr 2013
- 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
- The participants who age more than 18 year and admitted to the medical intensive care unit or intermediate care unit
- All participants must be retained the urinary catheter.
Who cannot join
- The participants were diagnosed urinary tract infection before retention of the urinary catheter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Non-returning Catheter Valve for Reducing Catheter-associated Urinary Tract Infection in Critically-ill Patients
This study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.
Read the detailed description
Non-returning catheter valve (generic name) used UnometerTM SafetiTM Plus (trade name)
- Being tested
- Non-returning catheter valve, Conventional urine bag
- Keywords
- Non-returning catheter valve, Catheter associated urinary tract infection, Critically ill patients, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-returning catheter valveDevice
Also called UnometerTM SafetiTM Plus
Conventional urine bagDevice
| Study group | Role | What they receive |
|---|---|---|
| Non-returning catheter valve | Experimental | Non-returning catheter valve (UnometerTM SafetiTM Plus) was used in experimental group only. Receives: Device: Non-returning catheter valve |
| Conventional urine bag | Active comparator | Conventional urine bag hasn't the non-returning catheter valve. Receives: Device: Conventional urine bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence density of the catheter associated urinary tract infection (CAUTI)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionApr 2013
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 Catheter Associated Urinary Tract InfectionStudies 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anupol Panitchote, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963013
- Sponsor's protocol ID
- CAUTI-001
- Status last verified
- Oct 2013
- First submitted
- 11 Oct 2013
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Panitchote A, Charoensri S, Chetchotisakd P, Hurst C. Pilot study of a non-return catheter valve for reducing catheter-associated urinary tract infections in critically ill patients. J Med Assoc Thai. 2015 Feb;98(2):150-5.
PubMed 25842795
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Non-returning Catheter Valve for Reducing Catheter-associated Urinary Tract Infection in Critically-ill Patients
- ClinicalTrials.gov ID
- NCT01963013
- Acronym / sponsor ID
- CAUTI-001
- Keywords
- Non-returning catheter valve, Catheter associated urinary tract infection, Critically ill patients, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Oct 2013 (estimated)
- 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 study was to determine efficacy of the non-returning catheter valve for reducing catheter associated urinary tract infection compared with conventional urine bag in critically ill patients.
Detailed description
Non-returning catheter valve (generic name) used UnometerTM SafetiTM Plus (trade name)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-returning catheter valve | Experimental | Device: Non-returning catheter valveNon-returning catheter valve (UnometerTM SafetiTM Plus) was used in experimental group only. |
| Conventional urine bag | Active comparator | Device: Conventional urine bagConventional urine bag hasn't the non-returning catheter valve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The participants who age more than 18 year and admitted to the medical intensive care unit or intermediate care unit
- All participants must be retained the urinary catheter.
Key exclusion criteria (1 listed)
- The participants were diagnosed urinary tract infection before retention of the urinary catheter.
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 |
|---|---|---|
| Non-returning catheter valveAlso: UnometerTM SafetiTM Plus | Device | Non-returning catheter valve |
| Conventional urine bag | Device | Conventional urine bag |
Primary outcome
Incidence density of the catheter associated urinary tract infection (CAUTI)
Time frame: one year
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 21 Oct 2013.
- Derived from this study: PubMed 25842795Panitchote A, Charoensri S, Chetchotisakd P, Hurst C. Pilot study of a non-return catheter valve for reducing catheter-associated urinary tract infections in critically ill patients. J Med Assoc Thai. 2015 Feb;98(2):150-5.
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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.
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 study testing Non-returning catheter valve and Conventional urine bag in people with Catheter Associated Urinary Tract Infection and Critically Ill Patients, run by Khon Kaen University at 1 site in Thailand.
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 2 inclusion and 1 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 21 Oct 2013. 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 Thailand. 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?
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?
Incidence density of the catheter associated urinary tract infection (CAUTI) (time frame: one year). 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 NCT01963013, 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 21 Oct 2013.