An interventional study of Restricted Reporting in Bacteriuria and Urinary Tract Infection, sponsored by Memorial University of Newfoundland. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by Memorial University of Newfoundland · Not applicable, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's enrollment of 110 is close to the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →Memorial University of Newfoundland is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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"
Behavioral: Restricted Reporting
Microbiology laboratory will report identification and susceptibility results
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
The Number of Patients Receiving Appropriate Treatment
Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
Time frame: 72 hours from positive culture
| Milestone | Restricted Reporting | Standard Reporting |
|---|---|---|
| Started | 55 | 55 |
| Completed | 55 | 55 |
| Not completed | 0 | 0 |
Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
| Participants | Restricted Reporting | Standard Reporting |
|---|---|---|
| The Number of Patients Receiving Appropriate Treatment | 44 | 29 |
Collected over 7 days after positive urine culture. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Restricted Reporting | 2/55 (3.6%) | 0/55 (0%) | 7/55 (12.7%) |
| Standard Reporting | 1/55 (1.8%) | 0/55 (0%) | 9/55 (16.4%) |
| Event | Restricted Reporting | Standard Reporting |
|---|---|---|
| TachycardiaCardiac disorders | 4/55 | 5/55 |
| Altered Mental StatusNervous system disorders | 2/55 | 5/55 |
| Elevated White Blood Cell CountBlood and lymphatic system disorders | 0/55 | 3/55 |
| TachypneaRespiratory, thoracic and mediastinal disorders | 0/55 | 3/55 |
| BacteremiaBlood and lymphatic system disorders | 1/55 | 2/55 |
| EdemaBlood and lymphatic system disorders | 1/55 | 1/55 |
| Abnormal Body TemperatureGeneral disorders | 0/55 | 0/55 |
| HyperglycaemiaEndocrine disorders | 0/55 | 0/55 |
110 Results randomized. All randomized results were analysed.
| Age, Continuous(years) | Restricted Reporting | Standard Reporting | Total |
|---|---|---|---|
| Mean | 67.7 ± 16.3 | 68.6 ± 16.0 | 68.1 ± 16.1 |
| Sex: Female, Male(Participants) | Restricted Reporting | Standard Reporting | Total |
|---|---|---|---|
| Female | 35 | 36 | 71 |
| Male | 20 | 19 | 39 |
| Race and Ethnicity Not Collected(Participants) | Restricted Reporting | Standard Reporting | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Restricted Reporting | Standard Reporting | Total |
|---|---|---|---|
| Canada | 55 | 55 | 110 |
| Asymptomatic Bacteriuria(Participants) | Restricted Reporting | Standard Reporting | Total |
|---|---|---|---|
| Count of participants | 35 | 41 | 76 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Memorial University of Newfoundland