- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03445312
Safety and Effectiveness of a Laboratory Intervention to Effectively NOT Treat Asymptomatic Bacteriuria (Salient)
Safety and Effectiveness of a Laboratory Intervention to Effectively NOT Treat Asymptomatic Bacteriuria (SALIENT-A)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The clinical information system for Mount Sinai Hospital will be programmed such that, whenever a mid-stream urine sample is received in the microbiology laboratory from medical and surgical wards, the specimen will be held rather than processed. The system will reflex a result the specimen (either at a set time twice daily, or at the time the specimen is accessioned) with a message saying: "The great majority of positive urine cultures from inpatients without an indwelling urinary catheter represent asymptomatic bacteriuria and are no longer routinely processed. If you strongly suspect that your patient has developed a urinary tract infection or if you have mislabeled this specimen, please call the Microbiology laboratory within 48 hours to request processing of this urine culture".
Any urine being held in the microbiology laboratory will automatically generate an email alert to the study coordinator. Within 24 hours of receipt of the urine culture, the coordinator will confirm that the specimen was a midstream urine specimen, interview the patient, determine if they have had any symptoms of a urinary tract infection, and collect information on what other symptoms of infection were present when the culture was ordered, why the culture was ordered, and whether antibiotic therapy was started empirically.
All patients whose urines have not been processed will have a second follow-up visit/call at 72-96 hours to ensure that urinary symptoms have not developed or worsened. If symptoms develop/worsen, the study coordinator will have the investigator follow up.
All patients will have a follow-up telephone call/visit 28-35 days after the specimen is obtained to identify any intercurrent infections (including C. difficile infection), and any potential complications/adverse effects from antibiotics. Permission will be obtained to contact family or other attending physicians to clarify any information if necessary.
Data collected for each patient will include: age, gender, underlying medical conditions, reason for hospitalization, date of admission to hospital, service at admission and at the time urine specimen obtained, date urine specimen obtained, whether or not urine culture processed, urine culture results and date reported (if the urine culture was processed), urinalysis results (if ordered), why the urine culture was ordered, whether the patient had fever, hypothermia, dysuria, urgency, frequency, costophrenic angle tenderness, increased incontinence, presence/absence of delirium, presence/absence of any other behavior changes, whether the patient was capable of reporting urinary tract symptoms, duration of each symptom, whether or not empiric antibiotics were ordered (name, dose, duration) at the time the specimen was ordered and what the indication for antibiotics was, what the whether or not antibiotics ordered empirically were stopped if the urine culture was reported as negative; whether empiric antibiotics were appropriate to the pathogen (if the urine was cultured), whether the antibiotic regimen was changed in response to culture results (urine or other); what the final diagnosis from the most responsible physician was regarding the episode for which the urine culture was ordered; whether the episode met NHSN criteria for any infection, whether the patient developed any adverse events potentially associated with antibiotics (includes solicited: nausea, vomiting, diarrhea (including CDI), rash, vaginitis, any allergic reaction) and unsolicited - if the unsolicited are known to be adverse events associated with the antibiotic in question (eg. Stevens-Johnson syndrome with Septra, achilles tendon rupture with fluoroquinolones). Data will be collected by chart review, and by interview with the patient/next of kin.
For each patient in whom a serious adverse event occurs, a case summary will be prepared. Based on the case summary, hospital chart, and study notes, two internists/infectious disease physicians, otherwise unrelated to the study will be asked independently to assess whether the serious adverse event was associated with the failure to process a urine culture (if one was not processed), or associated with antibiotic prescribed for asymptomatic bacteruria. If the two physicians disagree, a third physician will review, and the three will meet to arrive at a consensus. If consensus cannot be achieved, the event will be recorded as associated with not performing the culture or with the antibiotic if 2 physicians of the 3 agree.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- inpatients on medical or surgical units at Mount Sinai Hospital
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
study cohort
All non-ICU medicine and surgery patients at Sinai Health System who have a mid-stream urine culture ordered
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microbiology lab will not process culture unless called
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serious adverse events (SAE) associated with not processing urine culture
Time Frame: 30 days
|
serious adverse events associated with not processing urine culture
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in SAE
Time Frame: 30 days
|
Rate of serious adverse events in patients without symptoms who did and did not have urine specimens processed
|
30 days
|
SAE due to antibiotics
Time Frame: 30 days
|
Rate of serious adverse events due to antibiotic therapy in patients who received antibiotics for asymptomatic bacteriuria
|
30 days
|
Non-response
Time Frame: 4 days
|
Proportion of patients with symptomatic urinary tract infection (UTI) who did not respond to initial empiric antibiotics
|
4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allison McGeer, Sinai Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSH 16-0302E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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