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Modified Reporting of Positive Urine Cultures Collected From Long Term Care

Modified Reporting of Positive Urine Cultures Collected From Long Term Care, a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03554603
Enrollment
100
Registered
2018-06-13
Start date
2018-11-05
Completion date
2019-07-31
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Bacteriuria, Urinary Tract Infections

Keywords

Long term care, Urine culture

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

BEHAVIORALModified 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.

Sponsors

Memorial University of Newfoundland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

1. Positive urine cultures not collected from Long term care facility patients 2. Pregnancy 3. Antibiotic treatment at the time of collection 4. Patients known to have blood neutrophils \<1.0 within 7 days of urine collection

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics7 daysNumber of Participants Who Received Appropriate Antibiotic Treatment

Countries

Canada

Participant flow

Participants by arm

ArmCount
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.
51
Standard Reporting
Microbiology laboratory will report identification and susceptibility results
49
Total100

Baseline characteristics

CharacteristicModified ReportingStandard ReportingTotal
Age, Continuous76.1 years
STANDARD_DEVIATION 12.5
74.0 years
STANDARD_DEVIATION 17.7
75.0 years
STANDARD_DEVIATION 15.1
Asymptomatic Bacteriuria32 Participants30 Participants62 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Canada
51 Participants49 Participants100 Participants
Sex: Female, Male
Female
34 Participants35 Participants69 Participants
Sex: Female, Male
Male
17 Participants14 Participants31 Participants
Urinary Tract Infection19 Participants19 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 510 / 49
other
Total, other adverse events
34 / 5127 / 49
serious
Total, serious adverse events
0 / 511 / 49

Outcome results

Primary

Proportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics

Number of Participants Who Received Appropriate Antibiotic Treatment

Time frame: 7 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Modified ReportingProportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics31 Participants
Standard ReportingProportion of Asymptomatic Bacteriuria Treated With Antibiotics and Urinary Tract Infection Treated With Antibiotics25 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026