Urinary Tract InfectionsPhase 3CAUTIONNCT00795470
Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections.
A Phase 3 study testing Antimicrobial and Catheter change in people with Urinary Tract Infections, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Urinary tract infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alter outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Antimicrobial and Catheter change
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2014
- 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
- Adult ICU patient (≥ 18 years old)
- Admitted to the ICU for ≥ 96 hours
- Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
- Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
- Have received antimicrobial therapy that would cover the isolated organism(s) in the index urine culture for < 24 hours (i.e. therapy that does NOT cover the isolated organism(s) in the index urine culture of any duration or antimicrobial that covers the index urine organism for < 24 hours are permitted)
Who cannot join
- Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
- Anuria (< 50 mL/day)
- Imminent death within 48 hours or decision to withdraw supportive care by clinical team
- Neutropenia (< 500/mm3)
- Patient has an alternative infection and requires an antimicrobial that has a spectrum of activity which include all the organism(s) isolated from the index urine culture
- Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Concealed Randomized Double-blinded Placebo-controlled Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill
Urinary tract infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alter outcomes. Our previous studies have documented wide practice variations exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore, the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics, a practice that can increase the development of resistant bacteria.
The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change and/or systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone, urine catheter change alone, and both catheter change and antibiotics. Their clinical outcomes will be assessed.
Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial. Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.
- Conditions
- Urinary Tract Infections
- Being tested
- Antimicrobial, Catheter change
- Keywords
- urinary tract infection, critically ill, ICU, antimicrobial, Catheter associated urinary tract infections
- Medical subject headings
- Urinary Tract Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntimicrobialDrug
Appropriate antimicrobial based on urine culture results
Catheter changeDevice
Change urine catheter
| Study group | Role | What they receive |
|---|---|---|
| No catheter change no antimicrobial | No intervention | Urinary catheter will not be changed and no antimicrobials will be prescribed |
| Antimicrobial and catheter change | Active comparator | Not described Receives: Drug: Antimicrobial; Device: Catheter change |
| Catheter change and NO antimicrobial | Active comparator | Not described Receives: Device: Catheter change |
| Antimicrobial and NO catheter change | Active comparator | Not described Receives: Drug: Antimicrobial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled
none enrolled
Measured: 18 months
Protocol Adherence Rate
Measured: 18 months
Secondary outcomes (3)
ICU free days at Day 30
Measured: 30 days
Microbiologic Outcome
Measured: Day 7 and 14
Developement of resistance
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 posted21 Nov 2008 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Not pursuing the study due to funding issues
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 Unity Health TorontoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Mount Sinai Hospital, New York, The Ottawa Hospital, Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Jan Friedrich, DPhil, MD, MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795470
- Sponsor's protocol ID
- REB 08-287
- Acronym
- CAUTION
- Status last verified
- Nov 2015
- First submitted
- 20 Nov 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chant C, Dos Santos CC, Saccucci P, Smith OM, Marshall JC, Friedrich JO. Discordance between perception and treatment practices associated with intensive care unit-acquired bacteriuria and funguria: a Canadian physician survey. Crit Care Med. 2008 Apr;36(4):1158-67. doi: 10.1097/CCM.0b013e3181692af9.
PubMed 18379242
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Concealed Randomized Double-blinded Placebo-controlled Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill
- ClinicalTrials.gov ID
- NCT00795470
- Acronym / sponsor ID
- CAUTION / REB 08-287
- Conditions
- Urinary Tract Infections
- Keywords
- urinary tract infection, critically ill, ICU, antimicrobial, Catheter associated urinary tract infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not pursuing the study due to funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Mount Sinai Hospital, New York, The Ottawa Hospital, Sunnybrook Health Sciences Centre
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Nov 2008 (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 infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alter outcomes. Our previous studies have documented wide practice variations exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore, the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics, a practice that can increase the development of resistant bacteria.
The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change and/or systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone, urine catheter change alone, and both catheter change and antibiotics. Their clinical outcomes will be assessed.
Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial. Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No catheter change no antimicrobial | No intervention | –Urinary catheter will not be changed and no antimicrobials will be prescribed |
| Antimicrobial and catheter change | Active comparator | Drug: Antimicrobial, Device: Catheter change |
| Catheter change and NO antimicrobial | Active comparator | Device: Catheter change |
| Antimicrobial and NO catheter change | Active comparator | Drug: Antimicrobial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult ICU patient (≥ 18 years old)
- Admitted to the ICU for ≥ 96 hours
- Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
- Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
- Have received antimicrobial therapy that would cover the isolated organism(s) in the index urine culture for < 24 hours (i.e. therapy that does NOT cover the isolated organism(s) in the index urine culture of any duration or antimicrobial that covers the index urine organism for < 24 hours are permitted)
Key exclusion criteria (6 listed)
- Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
- Anuria (< 50 mL/day)
- Imminent death within 48 hours or decision to withdraw supportive care by clinical team
- Neutropenia (< 500/mm3)
- Patient has an alternative infection and requires an antimicrobial that has a spectrum of activity which include all the organism(s) isolated from the index urine culture
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 |
|---|---|---|
| AntimicrobialAppropriate antimicrobial based on urine culture results | Drug | Antimicrobial and NO catheter change, Antimicrobial and catheter change |
| Catheter changeChange urine catheter | Device | Antimicrobial and catheter change, Catheter change and NO antimicrobial |
Primary outcome
Number of patients enrolled
Time frame: 18 months
none enrolled
Protocol Adherence Rate
Time frame: 18 months
3 secondary outcomes
ICU free days at Day 30
Time frame: 30 days
Microbiologic Outcome
Time frame: Day 7 and 14
Developement of resistance
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 18379242Chant C, Dos Santos CC, Saccucci P, Smith OM, Marshall JC, Friedrich JO. Discordance between perception and treatment practices associated with intensive care unit-acquired bacteriuria and funguria: a Canadian physician survey. Crit Care Med. 2008 Apr;36(4):1158-67. doi: 10.1097/CCM.0b013e3181692af9.
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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.
Jan Friedrich, DPhil, MD, MSc principal investigator
Unity Health Toronto
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 Antimicrobial and Catheter change in people with Urinary Tract Infections, run by Unity Health Toronto at 1 site in Canada.
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 5 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: withdrawn, as of the sponsor's last update on 3 Dec 2015. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients enrolled (time frame: 18 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?
On the ClinicalTrials.gov record for NCT00795470, 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 3 Dec 2015.