TABLE 5.
Clinical outcomes and tolerability (n = 416)
| Parameter a | Value |
|---|---|
| Clinical success b | 315 (75.7) |
| 30-day survival | 394 (94.7) |
| Clinical improvement c | 350 (84.1) |
| Absence of microbiological recurrence d | 393 (94.5) |
| Microbiological recurrence | 23 (5.5) |
| Symptomatic | 19 (4.6) |
| Treated with antibiotic(s) | 19 (4.6) |
| Treatment-emergent resistance | 0 (0) |
| Hospital readmission | |
| 30-day | 77 (18.5) |
| 60-day e | 81 (23.9) |
| Positive culture on readmission f | 10 (6.3) |
| ERV on readmission f | 14 (8.9) |
| Adverse effects | 39 (9.4) |
| Nephrotoxicity | 4 (1) |
| Gastrointestinal intolerance g | 20 (4.8) |
| Electrolyte disturbance | 1 (0.2) |
| Encephalopathy | 3 (0.7) |
| Hepatotoxicity | 7 (1.7) |
| Dermatologic reaction | 1 (0.2) |
| Infusion site phlebitis | 2 (0.5) |
| Catheter site pain | 1 (0.2) |
| ERV discontinuation secondary to an adverse effect | 9/39 (23.1) |
| Gastrointestinal intolerance | 6/9 (66.7) |
| Hepatotoxicity | 3/9 (33.3) |
Data are presented as number (%).
Clinical success: Patient survival and absence of microbiological recurrence at 30 days from the end of eravacycline therapy and clinical improvement within 96 h of eravacycline initiation.
Clinical improvement: The resolution of infectious signs and symptoms including infection-related abnormal white blood cell count/temperature or as documented by the physician in clinical notes.
Microbiological recurrence: An isolate of the same bacteria (at species level) from the same culture source taken after a negative culture.
Patients with a 30-day readmission were muted from 60-day readmission total.
Percent based on a denominator of 158, representing the number of patients readmitted within 30 and/or 60 days.
Gastrointestinal intolerance defined as nausea, vomiting, and/or diarrhea.