TraumaPhase 3NCT00192985
Does a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma
A Phase 3 study testing Nitrofuranzone coated bladder catheter in people with Trauma and Urinary Tract Infections, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Urinary Tract Infections
- What is being tested?
- Nitrofuranzone coated bladder catheter
- Type of treatment
- Medical device
- How many people
- 216 participants
- Where
- 1 siteDenmark
- Study dates
- May 2003to Sep 2006
- Phase
- Phase 3
- 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
- Clinical suspicion of multiple trauma
- Age >/= 18 years
- Direct referral from scene of accident
- Indication for urinary bladder catherization
Who cannot join
- Major burn injury
- HIV positiv
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Copenhagen University Hospital
Copenhagen, DK-2100
About this study
Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.
Read the detailed description
Urinary tract infection occurs in one in five patients as a complication following severe trauma. A new and approved urinary bladder catheter (Releen NF) has been introduced by the Danish company Coloplast A/S. Releen NF is expected to reduce the number of urinary tract infections, but this effect has not been investigated in trauma patients.
- Conditions
- Trauma, Urinary Tract Infections
- Being tested
- Nitrofuranzone coated bladder catheter
- Medical subject headings
- Wounds and Injuries, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrofuranzone coated bladder catheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary tract infections
Secondary outcomes (1)
length of stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2003
- Study completionSep 2006
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 TraumaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 216 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Jakob Stensballe, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192985
- Sponsor's protocol ID
- KF 01-160/02 Catheter
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Publications
Stensballe J, Tvede M, Looms D, Lippert FK, Dahl B, Tonnesen E, Rasmussen LS. Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients: a randomized trial. Ann Intern Med. 2007 Sep 4;147(5):285-93. doi: 10.7326/0003-4819-147-5-200709040-00002.
PubMed 17785483
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma
- ClinicalTrials.gov ID
- NCT00192985
- Acronym / sponsor ID
- KF 01-160/02 Catheter
- Conditions
- Trauma, Urinary Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Sep 2006
- First posted
- 19 Sep 2005 (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.
Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.
Detailed description
Urinary tract infection occurs in one in five patients as a complication following severe trauma. A new and approved urinary bladder catheter (Releen NF) has been introduced by the Danish company Coloplast A/S. Releen NF is expected to reduce the number of urinary tract infections, but this effect has not been investigated in trauma patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical suspicion of multiple trauma
- Age >/= 18 years
- Direct referral from scene of accident
- Indication for urinary bladder catherization
Key exclusion criteria (3 listed)
- Major burn injury
- HIV positiv
- Pregnancy
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 |
|---|---|---|
| Nitrofuranzone coated bladder catheter | Device | – |
Primary outcome
urinary tract infections
1 secondary outcome
length of stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2005.
- Derived from this study: PubMed 17785483Stensballe J, Tvede M, Looms D, Lippert FK, Dahl B, Tonnesen E, Rasmussen LS. Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients: a randomized trial. Ann Intern Med. 2007 Sep 4;147(5):285-93. doi: 10.7326/0003-4819-147-5-200709040-00002.
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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.
Jakob Stensballe, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitrofuranzone coated bladder catheter in people with Trauma and Urinary Tract Infections, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 3 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 19 Sep 2005. 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
urinary tract infections. 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 NCT00192985, 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 19 Sep 2005.