Table 2. Efficacy Assessments by Therapeutic Response of Patients.
| Population | Patients, No. (%) | ||
|---|---|---|---|
| CIPRO+FLUO | CIPRO | FLUO | |
| Microbiological intent-to-treat population | |||
| Total No. | 103 | 91 | 45 |
| Visit 3 (primary end point) | |||
| Therapeutic cure | 63 (61.2) | 49 (53.8) | 20 (44.4) |
| Therapeutic failure | 40 (38.8) | 42 (46.2) | 25 (55.6) |
| Difference in response rate (95% CI)a | NA | 7.3 (–6.6 to 21.2) | 16.7 (–0.6 to 34.0) |
| P valueb | NA | .30 | .06 |
| Visit 4 | |||
| Therapeutic cure | 90 (87.4) | 69 (75.8) | 36 (80.0) |
| Therapeutic failure | 13 (12.6) | 22 (24.2) | 9 (20.0) |
| Difference in response rate (95% CI)a | NA | 11.6 (0.7 to 22.4) | 7.4 (–6.0 to 20.7) |
| P valueb | NA | .04 | .25 |
| Clinical intent-to-treat population | |||
| Total No. | 196 | 196 | 100 |
| Visit 3 | |||
| Therapeutic cure | 107 (54.3) | 94 (48.0) | 45 (45.0) |
| Therapeutic failure | 90 (45.7) | 102 (52.0) | 55 (55.0) |
| Difference in response rate (95% CI)a | NA | 6.4 (–3.5 to 16.2) | 9.3 (–2.7 to 21.3) |
| P valueb | NA | .21 | .13 |
| Visit 4 | |||
| Therapeutic cure | 175 (88.8) | 152 (77.6) | 82 (82.0) |
| Therapeutic failure | 22 (11.2) | 44 (22.4) | 18 (18.0) |
| Difference in response rate (95% CI)a | NA | 11.3 (4.0 to 18.6) | 6.8 (–1.9 to 16.6) |
| P valueb | NA | .003 | .10 |
| Sustained microbiological outcome in microbiological intent-to-treat populationc | |||
| Total No. | 103 | 91 | 45 |
| Therapeutic cure | 94 (91.3) | 74 (81.3) | 34 (75.6) |
| Therapeutic failure | 9 (8.7) | 17 (18.7) | 11 (24.4) |
| Difference in response rate (95% CI)a | NA | 9.9 (0.3 to 19.6) | 15.7 (2.0 to 29.4) |
| P valueb | NA | .04 | .01 |
Abbreviations: CIPRO, ciprofloxacin alone; CIPRO+FLUO, ciprofloxacin plus fluocinolone acetonide; FLUO, fluocinolone acetonide alone; NA, not applicable.
a
Calculated as response rate for combined treatment–response rate for individual component.
b
Calculated using the Pearson χ2 test for independence between the combined treatment and each individual component. If the assumptions of the χ2 test were not met, the P value was calculated using the Fisher exact test.
c
Sustained microbiological cure is achieved when there is a response of eradication or presumed eradication at both visits 3 and 4. Patients who discontinued because of lack of efficacy or rescue medication use were considered to have experienced treatment failure.