Table 1.
Baseline demographics and clinical characteristics of the modified intent-to-treat (MITT) population
| Characteristic | MITT population (n = 170) |
|---|---|
| Demographic characteristics | |
| Male, n (%) | 101 (59.4%) |
| Mean age (range) | 62.2 years (25−89) |
| Race, n (%) | |
| White | 160 (94.1%) |
| Other (includes unspecified) | 10 (5.9%) |
| Mean BMI (range)a | 25.7 kg/m2 (15.4–83.0) |
| Risk factors for candidaemia/invasive candidiasis, n (%) | |
| Broad-spectrum antibiotics | 153 (90.0%) |
| Central venous catheter | 148 (87.1%) |
| Prior surgery | 113 (66.5%) |
| Total parenteral nutrition | 99 (58.2%) |
| Dialysis/renal failure | 59 (34.7%) |
| Systemic steroids or other immunosuppressives/immunosuppressive therapy | 57 (33.5%) |
| Mucosal colonization by Candida species | 52 (30.6%) |
| Chemotherapy | 21 (12.4%) |
| Neutropaenia (neutrophil count <500/mm3) | 13 (7.6%) |
| HIV infection | 2 (1.2%) |
| Clinical characteristics | |
| Post-abdominal surgery | 90 (52.9%) |
| Elderly (≥65 years) | 80 (47.1%) |
| Renal insufficiency/failure/dialysisb | 67 (39.4%) |
| Solid tumour | 45 (26.5%) |
| Hepatic insufficiencyb | 27 (15.9%) |
| Neutropaenic | 13 (7.6%) |
| Solid organ transplant recipient | 10 (5.9%) |
| Infection site, n (%) | |
| Blood only | 114 (67.1%) |
| Other normally sterile site only | 49 (28.8%) |
| Blood and other normally sterile site | 7 (4.1%) |
| Mean Candida score (95% CI)c | 3.4 (3.2–3.6) |
| Mean colonization index (95% CI)d | 53.1 (45.7–60.6) |
| Mean SOFA score (95% CI)e | 7.2 (6.6–7.9) |
| Septic shockf | 41 (24.1%) |
| APACHE II score | |
| ≤20 | 128 (75.3%) |
| >20 | 42 (24.7%) |
| Mean (range) | 16.2 (4–26g) |
| Intravascular catheter status | |
| All catheters removed/replacedh | 40 (23.5%) |
| Not all catheters removed/replacedi | 49 (28.8%) |
| No catheter inserted before first positive culture | 81 (47.6%) |
| Baseline pathogen | |
| C. albicans | 95 (55.9%) |
| C. glabrata | 25 (14.7%) |
| C. parapsilosis | 17 (10.0%) |
| C. tropicalis | 13 (7.6%) |
| C. kefyr | 3 (1.8%) |
| C. dubliniensis | 2 (1.2%) |
| C. pelliculosa | 2 (1.2%) |
| Other Candida spp.j | 3 (1.8%) |
| Multiple Candida spp. | 10 (5.9%) |
APACHE II, Acute Physiology and Chronic Health Evaluation II; BMI, body mass index; SOFA, Sequential Organ Failure Assessment.
Assessed in n = 165 patients.
The presence/absence of these characteristics was determined by the local investigator; there were no prespecified protocol definitions.
Assessed in n = 167 patients.
Assessed in n = 90 patients, expressed as a percentage.
Assessed in n = 166 patients.
Defined as having ‘severe sepsis’ (per the Candida score assessment) and a value of 3 or 4 on the cardiovascular system component of the SOFA score.
A single patient with a score ≥25 (i.e. 26) was included in the MITT population.
Patients with ≥1 intravascular catheter inserted before the day of first positive culture, all of which were removed or replaced by day 3 of anidulafungin therapy.
Patients with ≥1 intravascular catheters inserted before the day of first positive culture, ≥1 of which had not been removed or replaced by day 3 of anidulafungin therapy.
One each of C. krusei, C. lusitaniae and C. norvegensis.