Table 3 Objectives and Outcome Measures
Objectives | Outcome Measures | Time Point(s) of evaluation of this outcome measure (if applicable) |
|---|---|---|
Primary Objective To compare disease-related outcome measures in dogs with presumed urinary tract infection treated with different duration (3, 4, 5, 6 or 7 day) regimens of amoxicillin/clavulanate. Find the shortest duration that is non-inferior to a duration of 7 days: | Optimal treatment duration in terms of proportion of dogs with resolution of lower urinary tract clinical signs as reported by the owner. Optimal is here defined as the shortest duration that is non-inferior to a duration of 7 days. The non-inferiority margin is set at 10 % [36]. | 1 day post treatment completion |
Secondary Objectives To compare recurrence rates within the 4 weeks of initial presentation after completion of different duration (3, 4, 5, 6 or 7Â day) regimens of amoxicillin/clavulanate | Proportion of dogs developing recurrence of lower urinary tract signs within 4 weeks of initial presentation | 28 days after initial presentation |
Exploratory Objectives In cases where urine culture is performed (not compulsory), to compare among groups: | Percentage of culture positive pre-treatment samples Percentage where bacteriological cure achieved | All |