N/A
N=100
Modified Reporting From Indwelling Catheters
Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT03488355 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Jan 2023
Primary outcome: Primary: Number of Participants With Appropriate Treatment — 31; 23 Participants — p=0.45
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Modified laboratory report (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial University of Newfoundland
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Appropriate Treatment |
31; 23 | 0.45 |
| SECONDARY Death |
4; 3 | — |
| SECONDARY Adverse Events |
13; 19 | — |
Summary
Positive urine cultures collected from indwelling catheters from inpatients will be randomized to standard reporting or modified reporting. Physician antibiotic treatment decisions will be prospectively observed and determined to be appropriate or inappropriate. The hypothesis is that modified reporting will lead to an increase in the percentage of appropriate therapy without an increase in pyelonephritis or sepsis.
Eligibility Criteria
Inclusion Criteria
- consecutive positive urine cultures collected from indwelling catheters in inpatients that are greater than or equal to 18 years of age.
- admitted to Health Sciences Center or St. Clare's Mercy hospitals only
Exclusion Criteria
- pregnancy
- antibiotic treatment at the time of collection
- patients in the Intensive Care Unit
- blood neutrophils count <1.0 x 10E9/l, within 7 days of urine collection
Data sourced from ClinicalTrials.gov (NCT03488355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.