Table 1. Demographic and Clinical Characteristics of Patients in the Clinical Intent-to-Treat Population.
| Characteristic | Patients, No. (%) | ||
|---|---|---|---|
| CIPRO+FLUO (n = 197) | CIPRO (n = 196) | FLUO (n = 100) | |
| Age, mean (SD), y | 37.8 (23.8) | 38.4 (22.6) | 38.7 (22.8) |
| <18 | 56 (28.4) | 57 (29.1) | 29 (29.0) |
| ≥18 | 141 (71.6) | 139 (70.9) | 71 (71.0) |
| Sex | |||
| Female | 97 (49.2) | 101 (51.5) | 56 (56.0) |
| Male | 100 (50.8) | 95 (48.5) | 44 (44.0) |
| Race and ethnicity | |||
| African American | 29 (14.7) | 30 (15.3) | 15 (15.0) |
| American Indian or Alaska native | 1 (0.5) | 2 (1.0) | 0 |
| Asian | 0 | 1 (0.5) | 2 (2.0) |
| White | 162 (82.2) | 161 (82.1) | 82 (82.0) |
| Othera | 5 (2.5) | 2 (1.0) | 1 (1.0) |
| Baseline pathogenb | 103 (52.3) | 91 (46.4) | 45 (45.0) |
| Pseudomonas aeruginosa | 37 (18.8) | 33 (16.8) | 16 (16.0) |
| Staphylococcus aureus | 26 (13.2) | 24 (12.2) | 8 (8.0) |
| Other pathogen | 64 (32.5) | 47 (24.0) | 30 (30.0) |
Abbreviations: CIPRO, ciprofloxacin alone; CIPRO+FLUO, ciprofloxacin plus fluocinolone acetonide; FLUO, fluocinolone acetonide alone.
a
In the CIPRO+FLUO group: 1 Central American patient, 2 Hispanic patients, 1 patient with race and ethnicity not known, and 1 biracial patient; in the CIPRO group: 2 Hispanic patients; in the FLUO group: 1 African American and White patient.
b
Each patient could have more than 1 pathogen.