Table 3. Cure Rate at Test-of-Cure Visit in the Overall Population and Relevant Subgroups*.
| Group with Clinical Cure | Clindamycin Group | TMP-SMX Group | Difference | P Value | ||
|---|---|---|---|---|---|---|
| no./total no. | % (95%, CI) | no./total no. | % (95%, CI) | percentage points | ||
| All patients | ||||||
| Intention-to-treat population | 212/264 | 80.3 (75.2 to 85.4) | 202/260 | 77.7 (72.3 to 83.1) | −2.6 (-10.2 to 4.9) | 0.52 |
| Population that could be evaluated | 212/237 | 89.5 (85.2 to 93.7) | 202/229 | 88.2 (83.7 to 92.7) | −1.2 (−7.6 to 5.1) | 0.77 |
|
| ||||||
| Children | ||||||
| Intention-to-treat population | 70/81 | 86.4 (78.1 to 94.7) | 60/74 | 81.1 (71.2 to 90.9) | −5.3 (−18.6 to 7.9) | 0.39 |
| Population that could be evaluated | 70/76 | 92.1 (85.2 to 99.0) | 60/67 | 89.6 (81.3 to 97.8) | −2.6 (−13.7 to 8.6) | 0.77 |
|
| ||||||
| Adults | ||||||
| Intention-to-treat population | 142/183 | 77.6 (71.1 to 84.1) | 142/186 | 76.3 (69.8 to 82.9) | −1.3 (−10.6 to 8.1) | 0.81 |
| Population that could be evaluated | 142/161 | 88.2 (82.8 to 93.6) | 142/162 | 87.7 (82.1 to 93.2) | −0.5 (−8.5 to 7.4) | 1.00 |
|
| ||||||
| Patients with cellulitis without abscess | ||||||
| Intention-to-treat population | 110/136 | 80.9 (73.7 to 88.0) | 110/144 | 76.4 (68.9 to 83.9) | −4.5 (−15.1 to 6.1) | 0.38 |
| Population that could be evaluated | 110/121 | 90.9 (85.2 to 96.6) | 110/127 | 86.6 (80.1 to 93.1) | −4.3 (−13.1 to 4.6) | 0.32 |
|
| ||||||
| Patients with abscess | ||||||
| Intention-to-treat population | 63/80 | 78.8 (68.9 to 88.6) | 64/80 | 80.0 (70.4 to 89.6) | 1.3 (−12.9 to 15.4) | 1.00 |
| Population that could be evaluated | 63/73 | 86.3 (77.5 to 95.1) | 64/72 | 88.9 (80.7 to 97.0) | 2.6 (−9.8 to 15.0) | 0.80 |
|
| ||||||
| Patients with mixed abscess and cellulitis | ||||||
| Intention-to-treat population | 39/47 | 83.0 (70.9 to 95.1) | 28/35 | 80.0 (65.0 to 95.0) | −3.0 (−23.0 to 17.0) | 0.78 |
| Population that could be evaluated | 39/43 | 90.7 (80.6 to 100) | 28/30 | 93.3 (82.5 to 100) | 2.6 (−13.0 to 18.3) | 1.00 |
|
| ||||||
| Patients with a single lesion in the intention-to-treat population | 136/170 | 80.0 (73.5 to 86.5) | 141/174 | 81.0 (74.8 to 87.3) | 1.0 (−8.1 to 10.2) | 0.89 |
|
| ||||||
| Patients with >1 lesion in the intention-to-treat population | 76/93 | 81.7 (73.1 to 90.3) | 61/85 | 71.8 (61.3 to 82.2) | −10.0 (−23.8 to 3.9) | 0.15 |
*
The actual confidence level was 95.60% after adjustment for interim analyses. P values for comparisons were determined with the use of Fisher's exact test.