Table 2.
Clinical outcome, microbiological outcome and mortality in patients treated with tigecycline according to FDA approved and non-approved indications.
| Indication | Duration of treatment (median; range) (Days) | T | Clinical Outcome | Microbiological Outcome | Mortality | ||||
|---|---|---|---|---|---|---|---|---|---|
| Success | Outcome NR | Success | Outcome NR | 7 days post-treatment mortality | In-hospital mortality | Total Mortality | |||
| FDA approved Indications | 29 | 16/25 (64%) | 4 | 6/12 (50%) | 17 | 3/29 (10.3%) | 2/29 (6.9%) | 5/29 (17.2%) | |
| cSSTI | 8 d; 3–18 d | 18 | 7/15 (46.7%) | 3 | 4/9 (44.4%) | 9 | 3/18 (16.7%) | 1/18 (5.6%) | 4/18 (22.2%) |
| cIAI | 6.5 d; 4–16 d | 4 | 3/4 (75%) | 0 | 1/2 (50%) | 2 | 0 | 0 | 0 |
| CAP | 7 d; 4–12 d | 8 | 6/7 (85.7%) | 1 | 1/2 (50%) | 6 | 1/8 (12.5%) | 0 | 1/8 (12.5%) |
| Off-label Indications | 124 | 43/111 (38.7%) | 13 | 20/48 (41.7%) | 76 | 48/124 (38.7%) | 16/124 (12.9%) | 64/124 (51.6%) | |
| HAP | 8 d; 3–26 d | 30 | 8/28 (28.6%) | 2 | 3/12 (25%) | 18 | 14/30 (46.7%) | 8/30 (26.7%) | 22/30 (73.3%) |
| VAP | 8 d; 3–19 d | 39 | 9/35 (25.7%) | 4 | 7/12 (58.3%) | 19 | 16/39 (41%) | 7/39 (18%) | 23/39 (59%) |
| Bacteremia | 8 d; 3–26 d | 23 | 7/21 (33.3%) | 2 | 4/18 (22.2%) | 5 | 6/23 (26.1%) | 0 | 6/23 (26.1%) |
| Sepsis | 9 d; 3–26 d | 14 | 1/14 (7.1%) | 0 | 0 | 13 | 13/14 (92.9%) | 0 | 13/14 (92.9%) |
| Diabetic Ulcer | 9 d; 3–19 d | 8 | 5/8 (62.5%) | 0 | 3/5 (60%) | 3 | 1/8 (12.5%) | 0 | 1/8 (12.5%) |
| UTI | 9.5 d; 3–24 d | 6 | 4/5 (80%) | 1 | 3/4 (75%) | 2 | 1/6 (16.7%) | 0 | 1/6 (16.7%) |
| FN | 7 d; 3–30 d | 24 | 16/19 (84.2%) | 5 | 4/4 (100%) | 20 | 3/24 (12.5%) | 0 | 3/24 (12.5%) |
CAP, Community Acquired Pneumonia; cIAI, complicated Intra-abdominal Infection; cSSTI, complicated Skin and Soft Tissue Infection; d, days; FDA, Food and Drug Administration; FN, Febrile Neutropenia; HAP, Hospital Acquired Pneumonia; NR, Not Reported; T, Total; UTI, Urinary Tract Infection; VAP, Ventilator Associated Pneumonia.
Microbiological Success Rate (per each indication) = Number of patients with microbiological success/(T-Outcome NA) × 100.
Clinical Success Rate (per each indication) = Number of patients with clinical success/(T-Outcome NA) × 100.
In the Mortality section, the denominator is always the total per each indication. The numerator in the “total mortality” is the sum of that in the “7 days post-treatment mortality” and that of the “in-hospital mortality.”