Table 2. Characteristics of Patients During the Trial in the Primary Analysis Population.
Characteristics | Combination Therapy (n = 174) | Standard Therapy (n = 178) |
---|---|---|
Final diagnosis of infective endocarditis, No. (%)a | 26 (15) | 16 (9) |
Received vancomycin, No. (%)b | 171 (98) | 178 (100) |
Received daptomycin, No. (%)b | 7 (4) | 6 (3) |
Trough vancomycin level, mean (SD), μg/mL | ||
Day 1 | 15.1 (8.1) | 14.7 (7.3) |
Day 2 | 17.9 (9.1) | 17.2 (8.0) |
Day 3 | 20.1 (7.6) | 19.2 (7.5) |
Received any nonstudy antibiotic during days 1-7, No. (%)c | 53 (30) | 48 (27) |
Infectious diseases consultation, No. (%) | 168 (97) | 171 (96) |
Presumed infected source removed, No. (%) | 77/106 (73) | 84/105 (80) |
Time to removal of infected source, median (IQR), dd | 0.0 (−1.0 to 2.0) | 0.0 (−1.0 to 2.0) |
Echocardiogram performed, No. (%) | 161 (93) | 168 (94) |
Transthoracic | 151 (87) | 151 (85) |
Transesophageal | 61 (35) | 68 (38) |
Abbreviation: IQR, interquartile range.
The final diagnosis of infective endocarditis was defined by modified Duke criteria. Numbers differ from those recognized with infective endocarditis at baseline because further investigations were performed.
Some patients may have received both vancomycin and daptomycin during their time in the study.
The 5 most common nonstudy antibiotics were piperacillin-tazobactam (combination: n = 18; standard: n = 15), ceftriaxone (combination: n = 15; standard: n = 11), gentamicin (combination: n = 9; standard: n = 5), azithromycin (combination: n = 9; standard: n = 4), and metronidazole (combination: n = 5; standard: n = 5). Participants may have received more than 1 nonstudy antibiotic.
The source may have been removed prior to randomization, with days prior to randomization counted as a negative number of days. Patients may have had multiple infected sources. Removal of a presumed infected source included removal of vascular lines and foreign devices as well as procedures such as drainage of skin abscesses, drainage of deep or visceral abscesses, debridement of infected tissue, and operative joint irrigation and drainage.