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Restricted Reporting for Positive Urine Cultures
NA trial testing Restricted Reporting in Bacteriuria in 110 participants. Completed in 1 May 2017.
| Lead sponsor | Memorial University of Newfoundland |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 1 January 2017 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 May 2017 |
| Sites | 1 location across Canada |
Memorial University of Newfoundland
18 and older, any sex, with Bacteriuria or Urinary Tract Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sum of urinary tract infection treated and asymptomatic bacteriuria not treated
| Group | Value | 95% CI |
|---|---|---|
| Restricted Reporting | 44 | |
| Standard Reporting | 29 |
Time frame: 7 days after positive urine culture. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Restricted Reporting | Standard Reporting |
|---|---|---|---|
| Tachycardia | Cardiac disorders | — | — |
| Altered Mental Status | Nervous system disorders | — | — |
| Elevated White Blood Cell Count | Blood and lymphatic system disorders | — | — |
| Tachypnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Bacteremia | Blood and lymphatic system disorders | — | — |
| Edema | Blood and lymphatic system disorders | — | — |
| Abnormal Body Temperature | General disorders | — | — |
| Hyperglycaemia | Endocrine disorders | — | — |
Data from ClinicalTrials.gov NCT02797613 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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