Urinary Tract InfectionNCT00927316
E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
A study testing E. coli 83972 in people with Urinary Tract Infection, run by Region Skane at 1 site in Sweden.
Trial summary
This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- E. coli 83972
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2003to Dec 2006
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent UTI
- Bladder emptying dysfunction
- Optimal conservative treatment incl. clean intermittent catheterization
- Capable of "self reporting of UTI episodes"
Who cannot join
- Malignant disease
- Immunosuppression
- Recurrent pyelonephritis
- Abnormalities within upper urinary tract, including renal stones and poor kidney function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.
This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.
- Conditions
- Urinary Tract Infection
- Being tested
- E. coli 83972
- Keywords
- Report of Urinary Tract Infection episode
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli 83972Biological
Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml).
Placebo arm: Identical procedure but with saline, 30 ml.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | E. coli 83972 bacteriuria Receives: Biological: E. coli 83972 |
| Placebo arm | Placebo comparator | Monitoring Receives: Biological: E. coli 83972 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to UTI
Measured: 12 months
Number of UTI
Measured: During 12 months placebo or active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startMar 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Coloplast A/S, Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden, Swedish Institute for Infectious Disease Control, Lund University Hospital
- Investigators
- Fredrik Sundén, MD, Principal investigator, Dept. of Urology, University Hospital, 221 85 LundBjörn Wullt, MD, PhD, Study chair, Dept. of Urology, Lund University Hospital, 221 85 Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927316
- Sponsor's protocol ID
- RTP-A2003
- Status last verified
- Nov 2009
- First submitted
- 22 Jun 2009
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.
- ClinicalTrials.gov ID
- NCT00927316
- Acronym / sponsor ID
- RTP-A2003
- Conditions
- Urinary Tract Infection
- Keywords
- Report of Urinary Tract Infection episode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Coloplast A/S, Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden, Swedish Institute for Infectious Disease Control, Lund University Hospital
- Study start
- Mar 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 24 Jun 2009 (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 tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Biological: E. coli 83972E. coli 83972 bacteriuria |
| Placebo arm | Placebo comparator | Biological: E. coli 83972Monitoring |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recurrent UTI
- Bladder emptying dysfunction
- Optimal conservative treatment incl. clean intermittent catheterization
- Capable of "self reporting of UTI episodes"
Key exclusion criteria (4 listed)
- Malignant disease
- Immunosuppression
- Recurrent pyelonephritis
- Abnormalities within upper urinary tract, including renal stones and poor kidney function
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 |
|---|---|---|
| E. coli 83972Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml). Placebo arm: Identical procedure but with saline, 30 ml. | Biological | Active arm, Placebo arm |
Primary outcome
Time to UTI
Time frame: 12 months
Number of UTI
Time frame: During 12 months placebo or active treatment
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 10 Nov 2009.
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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.
Fredrik Sundén, MD principal investigator
Dept. of Urology, University Hospital, 221 85 Lund
Björn Wullt, MD, PhD study chair
Dept. of Urology, Lund University Hospital, 221 85 Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E. coli 83972 in people with Urinary Tract Infection, run by Region Skane at 1 site in Sweden.
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 4 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 10 Nov 2009. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Time to UTI (time frame: 12 months). The study lists 2 primary outcomes in all. 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 10 Nov 2009.