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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 |
|---|---|---|---|
| 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" |
|
| Standard Reporting | No Intervention | Microbiology laboratory will report identification and susceptibility results |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Report | 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 |
|---|---|---|
| Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics | Number of Participants Who Received Appropriate Antibiotic Treatment | 7 days |
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Inclusion Criteria:
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).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Center | St. John's | Newfoundland and Labrador | A1B3V6 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified 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" Modified 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. |
| FG001 | Standard Reporting | Microbiology laboratory will report identification and susceptibility results |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified 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" Modified 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. |
| 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 | Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics | Number of Participants Who Received Appropriate Antibiotic Treatment | Posted | Count of Participants | Participants | 7 days |
|
30 days
Bacteremia during the trial was considered a serious adverse event
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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 | Modified 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" Modified 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Infections and infestations | Systematic Assessment | Positive blood culture during study period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Daley MD MSc | Memorial University | 7097772089 | 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 | May 1, 2018 | Sep 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| 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 | Count of Participants | Participants |
|
| Urinary Tract Infection | Count of Participants | Participants |
|
| Asymptomatic Bacteriuria | Count of Participants | Participants |
|
Microbiology laboratory will report identification and susceptibility results |
|
|
| 2 |
| 51 |
| 0 |
| 51 |
| 34 |
| 51 |
| EG001 | Standard Reporting | Microbiology laboratory will report identification and susceptibility results | 0 | 49 | 1 | 49 | 27 | 49 |
|
| Abnormal Temperature | Investigations | Non-systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Elevated White Blood Cell Count | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | Non-systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |