Bacteriuria, Urinary Tract Infection
Conditions
Brief 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. 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.
Interventions
BEHAVIORALRestricted Reporting
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
Sponsors
Memorial University of Newfoundland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* positive urine culture from inpatients at Health Sciences Centre or St. Clare's Mercy Hospital or outpatients during study period.
Exclusion criteria
* pregnancy, * antibiotic treatment at the time of urine collection, * collection from an indwelling catheter, * admission to long term care facility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients Receiving Appropriate Treatment | 72 hours from positive culture | Sum of urinary tract infection treated and asymptomatic bacteriuria not treated |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restricted Reporting 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
Restricted Reporting: 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 | 55 |
| Standard Reporting Microbiology laboratory will report identification and susceptibility results | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | Restricted Reporting | Standard Reporting | Total |
|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 16.3 | 68.6 years STANDARD_DEVIATION 16 | 68.1 years STANDARD_DEVIATION 16.1 |
| Asymptomatic Bacteriuria | 35 Participants | 41 Participants | 76 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 35 Participants | 36 Participants | 71 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 55 | 1 / 55 |
| other Total, other adverse events | 7 / 55 | 9 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
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
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Restricted Reporting | The Number of Patients Receiving Appropriate Treatment | 44 Participants |
| Standard Reporting | The Number of Patients Receiving Appropriate Treatment | 29 Participants |