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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restricted 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" |
|
| Standard Reporting | No Intervention | Microbiology laboratory will report identification and susceptibility results |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restricted Reporting | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Receiving Appropriate Treatment | Sum of urinary tract infection treated and asymptomatic bacteriuria not treated | 72 hours from positive culture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Daley, MD FRCPC | Memorial University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Center | St. John's | Newfoundland and Labrador | A1B3V6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29804552 | Derived | Daley P, Garcia D, Inayatullah R, Penney C, Boyd S. Modified Reporting of Positive Urine Cultures to Reduce Inappropriate Treatment of Asymptomatic Bacteriuria Among Nonpregnant, Noncatheterized Inpatients: A Randomized Controlled Trial. Infect Control Hosp Epidemiol. 2018 Jul;39(7):814-819. doi: 10.1017/ice.2018.100. Epub 2018 May 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard Reporting | Microbiology laboratory will report identification and susceptibility results |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
110 Results randomized. All randomized results were analysed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Patients Receiving Appropriate Treatment | Sum of urinary tract infection treated and asymptomatic bacteriuria not treated | Intention to treat | Posted | Count of Participants | Participants | 72 hours from positive culture |
|
7 days after positive urine culture
Bacteremia and Death reported at 7 days follow up, Adverse events (systemic inflammatory response syndrome) reported at 72 hours follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Blood and lymphatic system disorders | Systematic Assessment | 7 days after positive urine culture |
Our design is a proof-of-concept which will require additional trials to verify. It would be impractical to manually screen all inpatient urine specimens using our inclusion criteria, although automated eligibility screening may be possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Daley | Memorial University | 7097250240 | pkd336@mun.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2016 | Feb 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001437 | Bacteriuria |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| BG001 | Standard Reporting | Microbiology laboratory will report identification and susceptibility results |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Asymptomatic Bacteriuria | Count of Participants | Participants |
|
| Standard Reporting |
Microbiology laboratory will report identification and susceptibility results |
|
|
| 2 |
| 55 |
| 0 |
| 55 |
| 7 |
| 55 |
| EG001 | Standard Reporting | Microbiology laboratory will report identification and susceptibility results | 1 | 55 | 0 | 55 | 9 | 55 |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | Systematic Assessment |
|
| Abnormal Body Temperature | General disorders | Systematic Assessment |
|
| Hyperglycaemia | Endocrine disorders | Systematic Assessment |
|
| Elevated White Blood Cell Count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | Systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |