Urinary Tract InfectionsNCT03554603
Modified Reporting of Positive Urine Cultures Collected From Long Term Care
A study testing Modified Report in people with Urinary Tract Infections and Asymptomatic Bacteriuria, run by Memorial University of Newfoundland at 1 site in Canada.
Trial summary
Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections, Asymptomatic Bacteriuria
- What is being tested?
- Modified Report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).
Who cannot join
- Positive urine cultures not collected from Long term care facility patients
- Pregnancy
- Antibiotic treatment at the time of collection
- Patients known to have blood neutrophils <1.0 within 7 days of urine collection
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Center
St. John's, Newfoundland and Labrador, A1B3V6
About this study
Official title: Modified Reporting of Positive Urine Cultures Collected From Long Term Care, a Randomized Controlled Trial
Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.
Read the detailed description
Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.
- Conditions
- Urinary Tract Infections, Asymptomatic Bacteriuria
- Being tested
- Modified Report
- Keywords
- Long term care, Urine culture
- 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.
Modified ReportBehavioural
Also called Restricted Report
An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.
| Study group | Role | What they receive |
|---|---|---|
| Modified Reporting | Experimental | Microbiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results" Receives: Behavioral: Modified Report |
| Standard Reporting | No intervention | Microbiology laboratory will report identification and susceptibility results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics
Number of Participants Who Received Appropriate Antibiotic Treatment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start5 Nov 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Daley, Memorial University of Newfoundland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554603
- Sponsor's protocol ID
- MUN-04
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2018
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Reporting of Positive Urine Cultures Collected From Long Term Care, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03554603
- Acronym / sponsor ID
- MUN-04
- Conditions
- Urinary Tract Infections, Asymptomatic Bacteriuria
- Keywords
- Long term care, Urine culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.
Detailed description
Positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. Physician or patient consent will not be collected. Patient records will be assessed by the investigator to determine if patients have AB or urinary tract infection. Physician antibiotic treatment decision in both groups will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Reporting | Experimental | Behavioral: Modified ReportMicrobiology laboratory will report "Positive urine cultures may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call 777-xxxx (researcher mobile phone) for identification and susceptibility results" |
| Standard Reporting | No intervention | –Microbiology laboratory will report identification and susceptibility results |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Consecutive positive urine cultures collected from patients admitted to Long term care facilities will be included. All methods of urine collection will be included (midstream, in-and-out catheterization, indwelling catheter).
Key exclusion criteria (4 listed)
- Positive urine cultures not collected from Long term care facility patients
- Pregnancy
- Antibiotic treatment at the time of collection
- Patients known to have blood neutrophils <1.0 within 7 days of urine collection
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 |
|---|---|---|
| Modified ReportAlso: Restricted ReportAn abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important. | Behavioural | Modified Reporting |
Primary outcome
Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics
Time frame: 7 days
Number of Participants Who Received Appropriate Antibiotic Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Modified Report in people with Urinary Tract Infections and Asymptomatic Bacteriuria, run by Memorial University of Newfoundland 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 1 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 1 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics (time frame: 7 days). 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 1 Mar 2024.