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The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis decision support on different aspects of antibiotic consumption when implemented alone or together.
This interventional study in two centers compares two groups with each other and with a pre-intervention control group. In group 1 rapid techniques for handling urine cultures will be the only intervention. In group 2 rapid diagnostics will be supplemented with real-time antimicrobial stewardship decision support (RADS). In each center two departments will be involved.
Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination and screened for inclusion in the interventional study.
In one of the centers, rapid techniques will be coupled to real-time antimicrobial stewardship decision support (RADS). RADS will be given by telephone to a designated clinician with the aim of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid diagnostics | Other | patients admitted to medical and surgical wards with urinary tract infections at Ã…lesund Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics alone will be implemented. |
|
| Rapid diagnostics and RADS | Other | patients admitted to medical and surgical wards with urinary tract infections at Molde Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics will be implemented in conjunction with Real-time antimicrobial stewardship decision support : rapid diagnostics and RADS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid diagnostics alone | Diagnostic Test | Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause 30-day mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to guidelines for empirical therapy | Antibiotics given before results of microbiology diagnostics. | Recorded at inclusion or within 30 days after admission/inclusion. |
| Total antibiotic consumption in intervention groups and control group compared |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Einar Nilsen, MD | Møre and Romsdal Health Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ã…lesund Hospital | Ã…lesund | Norway | ||||
| Molde Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22831285 | Background | Nilsen E. Automated identification and susceptibility determination directly from blood cultures facilitates early targeted antibiotic therapy. Scand J Infect Dis. 2012 Nov;44(11):860-5. doi: 10.3109/00365548.2012.689848. Epub 2012 Jul 25. |
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No IPD will be shared with other investigators.
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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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| ID | Term |
|---|---|
| D000092025 | Rapid Diagnostic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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|
| Real-time antimicrobial stewardship decision support | Other | A clinical microbiologist will be give RADS by phone to a designated clinician with the aim of:
|
|
|
Total consumption of antibiotic during admission and prescribed oral antibiotics after discharge. Expressed in (DDD) "the assumed average maintenance dose per day for the drug used for its main indication in adults" / admission |
| Recorded at inclusion or within 30 days after admission/inclusion. |
| Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group. | Recorded 30 days after admission/inclusion. |
| Time from admission to optimal antibiotic therapy | Optimal treatment is defined as the working treatment with the most narrow spectrum possible | Recorded 30 days after admission/inclusion. |
| Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment | Recorded within 30 days after admission/inclusion. |
| Treatment duration - intravenous/per oral | Recorded within 30 days after admission/inclusion. |
| Intensive care unit length of stay | Recorded within 30 days after admission/inclusion. |
| Hospital length of stay | Recorded within 30 days after admission/inclusion. |
| Frequency of adherence to treatment suggestions given as RADS | Recorded within 30 days after admission/inclusion. |
| Frequency of readmission for urinary tract infection within 30 days of discharge | Recorded within 30 days after admission/inclusion. |
| Turnaround time of rapid diagnostic procedures compared to conventional diagnostics | Recorded within 30 days after admission/inclusion. |
| Accuracy of rapid diagnostic procedures compared to conventional diagnostics | Recorded within 30 days after admission/inclusion. |
| Molde |
| Norway |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000067716 | Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |