Table 3. Outcomes at Test-of-Cure Visit.
| Criteria | No./Total No. (%) | Difference, % (1-Sided 97.5% CI) | |
|---|---|---|---|
| Algorithm-Based Therapy | Usual Practice | ||
| Overall success in the ITT populationa | 209/255 (82.0) | 207/254 (81.5) | 0.5 (−6.2 to ∞) |
| Success according to assessment of complicationb | |||
| Simple or uncomplicated bacteremia | 173/209 (82.8) | 191/221 (86.4) | −3.7 (−10.5 to 3.2) |
| Complicated bacteremia | 36/42 (85.7) | 16/29 (55.2) | 30.5 (9.6 to 51.5) |
| Success according to clinical category | |||
| All Staphylococcus aureus | 43/57 (75.4) | 39/59 (66.1) | 9.3 (−7.1 to ∞) |
| Uncomplicated S aureus | 24/34 (70.6) | 34/45 (75.6) | −5.0 (−24.8 to ∞) |
| Complicated S aureus | 19/23 (82.6) | 5/14 (35.7) | 46.9 (17.4 to ∞) |
| All coagulase-negative staphylococci | 166/194 (85.6) | 168/191 (88.0) | −2.4 (−9.2 to ∞) |
| Simple coagulase-negative staphylococci | 115/136 (84.6) | 109/124 (87.9) | −3.3 (−11.7 to ∞) |
| Observed without antibiotics | 37/46 (80.4) | 35/38 (92.1) | −11.7 (−26.0 to ∞) |
| Treated with antibiotics | 78/90 (86.7) | 74/86 (86.0) | 0.6 (−9.5 to ∞) |
| Uncomplicated coagulase-negative staphylococci | 34/39 (87.2) | 48/52 (92.3) | −5.1 (−17.9 to ∞) |
| Complicated coagulase-negative staphylococci | 17/19 (89.5) | 11/15 (73.3) | 16.1 (−10.2 to ∞) |
| Overall success in the per-protocol population | 185/207 (89.4) | 178/203 (87.7) | 1.7 (−4.5 to ∞) |
| Success according to pathogen in the ITT populationc | |||
| S aureus | |||
| Methicillin-susceptible | 33/45 (73.3) | 23/38 (60.5) | 12.8 (−7.4 to ∞) |
| Methicillin-resistant | 10/12 (83.3) | 16/21 (76.2) | 7.1 (−20.7 to ∞) |
| Coagulase-negative staphylococci | |||
| Methicillin-susceptible | 81/90 (90.0) | 82/88 (93.2) | −3.2 (−11.3 to ∞) |
| Methicillin-resistant | 84/98 (85.7) | 86/100 (86.0) | −0.3 (−10.0 to ∞) |
Abbreviation: ITT, intention-to-treat.
In a sensitivity analysis in which missing data were treated as missing, results were similar (success, 209/223 [93.7%] in the algorithm-based therapy group vs 207/221 [93.7%] in the usual practice group; difference, 0.1 [1-sided 97.5% CI, −4.5 to ∞]). In the post hoc multiple imputation analysis, results were also similar (difference, 0.2 [1-sided 97.5% CI, −5.6 to ∞]). See also eTable 6 in Supplement 2.
Final classification as simple, uncomplicated, or complicated bacteremia was established after completion of the baseline evaluation, including follow-up blood cultures and echocardiography. Patients with complicated bacteremia were enrolled with suspected simple or uncomplicated bacteremia but were subsequently found to have complicated infection at baseline.
Methicillin susceptibility testing was not available for 9 (2.3%) coagulase-negative staphylococci isolates (5 with simple coagulase-negative staphylococci and 1 with uncomplicated coagulase-negative staphylococci in the algorithm-based therapy group, and 2 with simple coagulase-negative staphylococci and 1 with uncomplicated coagulase-negative staphylococci in the usual practice group).