Urinary Tract Infection, Antibiotic UseNCT00243360
Optimizing Antibiotic Use in Long Term Care
A study testing diagnostic and treatment clinical algorithms in people with Urinary Tract Infection, Antibiotic Use, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in Canada.
Trial summary
The purpose of this study was to determine if a multi-faceted intervention to implement diagnostic and therapeutic algorithms for management of suspected urinary infection in nursing home residents could reduce antibiotic prescribing for urinary indications in this population. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Urinary Tract Infection, Antibiotic Use
- What is being tested?
- diagnostic and treatment clinical algorithms
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Jan 2001to Jul 2003
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals- all residents eligible
- Nursing homes
- Free standing long term care facilities with >100 beds
- No stated policy for diagnosis or treatment of urinary tract infections
- The facility agrees to refrain from introducing new strategies for antibiotic utilization or clinical pathways during study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine if a multi-faceted intervention to implement diagnostic and therapeutic algorithms for management of suspected urinary infection in nursing home residents could reduce antibiotic prescribing for urinary indications in this population.
Read the detailed description
Antibiotic use is intense in nursing homes and frequently inappropriate when prescribed for urinary indications. Evidence from randomized controlled trials suggests that treatment of asymptomatic bacteriuria, the presence of bacteria in the urine in the absence of urinary symptoms, is not beneficial. Despite this, one in three prescriptions for urinary indications are for asymptomatic bacteriuria. To improve antibiotic prescribing in this setting we conducted a cluster randomized trial of a strategy to implement diagnostic and treatment algorithms for urinary infection. 24 nursing homes were randomized to either the intervention (implemented at the nursing home level using a multi-faceted approach: small group interactive sessions for nurses, one-on-one interviews for physicians, videotapes, written material, and outreach visits) or to usual care.
- Conditions
- Urinary Tract Infection, Antibiotic Use
- Being tested
- diagnostic and treatment clinical algorithms
- Keywords
- Urinary tract infections,, antibiotic use,, long term care facilities
- 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.
diagnostic and treatment clinical algorithmsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial prescriptions
Secondary outcomes (2)
Urinary cultures,
hospitalizations, deaths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startJan 2001
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection, Antibiotic UseStudies 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Investigators
- Mark B Loeb, MD MSc FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243360
- Sponsor's protocol ID
- U18HS011113-01
- Status last verified
- Oct 2005
- First submitted
- 21 Oct 2005
- Last updated
- 24 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antibiotic Use in Long Term Care
- ClinicalTrials.gov ID
- NCT00243360
- Acronym / sponsor ID
- U18HS011113-01
- Conditions
- Urinary Tract Infection, Antibiotic Use
- Keywords
- Urinary tract infections,, antibiotic use,, long term care facilities
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Jan 2001
- Study completion
- Jul 2003
- First posted
- 24 Oct 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.
The purpose of this study was to determine if a multi-faceted intervention to implement diagnostic and therapeutic algorithms for management of suspected urinary infection in nursing home residents could reduce antibiotic prescribing for urinary indications in this population.
Detailed description
Antibiotic use is intense in nursing homes and frequently inappropriate when prescribed for urinary indications. Evidence from randomized controlled trials suggests that treatment of asymptomatic bacteriuria, the presence of bacteria in the urine in the absence of urinary symptoms, is not beneficial. Despite this, one in three prescriptions for urinary indications are for asymptomatic bacteriuria. To improve antibiotic prescribing in this setting we conducted a cluster randomized trial of a strategy to implement diagnostic and treatment algorithms for urinary infection. 24 nursing homes were randomized to either the intervention (implemented at the nursing home level using a multi-faceted approach: small group interactive sessions for nurses, one-on-one interviews for physicians, videotapes, written material, and outreach visits) or to usual care.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals- all residents eligible
- Nursing homes
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| diagnostic and treatment clinical algorithms | Behavioural | – |
Primary outcome
Antimicrobial prescriptions
2 secondary outcomes
Urinary cultures,
hospitalizations, deaths
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 24 Oct 2005.
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.
Mark B Loeb, MD MSc FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic and treatment clinical algorithms in people with Urinary Tract Infection, Antibiotic Use, run by Agency for Healthcare Research and Quality (AHRQ) 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 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 24 Oct 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 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.
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?
Antimicrobial prescriptions. 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 24 Oct 2005; AzTrials last refreshed its copy on 27 Oct 2026.