Table 3.
Effectiveness outcomes
| Effectiveness outcome, n (% [95% CI]) | Cephalexin 500 mg plus placebo | Cephalexin 1000 mg |
|---|---|---|
| N = 31 (50.0%) | N = 31 (50.0%) | |
| Oral antibiotic treatment failure* | 4 (12.9% [5.1–28.9%]) | 1 (3.2% [0.6–16.2%]) |
| Change in class of oral antibiotic | 3 (9.7% [3.4–24.9%]) | 0 (0.0% [0.0–11.0%] |
| Switch to intravenous antibiotic | 1 (3.2% [0.6–16.2%]) | 1 (3.2% [0.6–16.2%]) |
| Clinical response† (day 3) | 19 (61.3% [43.8–76.3%]) | 18 (58.1% [40.8–73.6%]) |
| Clinical cure¶ | ||
| Day 7 | 2 (6.5% [1.8–20.7%]) | 5 (16.1% [7.1–32.6%]) |
| Day 14 | 12 (38.7% [23.7–56.2%]) | 14 (45.2% [29.2–62.2%]) |
| Adverse events | 8 (25.8% [13.7–43.3%]) | 12 (38.7% [23.7–56.2%]) |
| Nausea or vomiting | 1 (3.2% [0.6–16.2%]) | 3 (9.7% [3.4–24.9%]) |
| Diarrhea | 2 (6.5% [1.8–20.7%]) | 5 (16.1% [7.1–32.6%]) |
| Abdominal pain | 0 (0.0% [0.0–11.0%]) | 1 (3.2% [0.6–16.2%]) |
| Rash | 2 (6.5% [1.8–20.7%]) | 1 (3.2% [0.6–16.2%]) |
| Other | 3 (9.7% [3.4–24.9%]) | 2 (6.5% [1.8–20.7%]) |
| None | 23 (74.2% [56.8–86.3%]) | 19 (61.3% [43.8–76.3%]) |
| Unplanned visit to family doctor within 14 d | 2 (6.5% [1.8–20.7%]) | 2 (6.5% [1.8–20.7%]) |
| Unplanned return ED visit within 14 d | 5 (16.1% [7.1–32.6%]) | 7 (22.6% [11.4–39.8%]) |
| Unplanned hospitalization within 14 d | 0 (0.0% [0.0–11.0%]) | 0 (0.0% [0.0–11.0%]) |
ED emergency department
*Treatment failure: change in antibiotic (class of oral antibiotic or step up to intravenous antibiotic) within 7 days due to worsening infection: (a) new fever or persistent fever; or (b) increasing area of erythema ≥ 20% from baseline; or (c) increasing pain ≥ 2 points from baseline using the numeric rating scale
†Clinical response: ≥ 20% reduction in area of erythema at day 3
¶Clinical cure: no erythema, pain or fever