Table 2.
Primary and secondary outcomes according to the study period in the intention-to-treat population
| Total population n = 1416 |
Control period n = 685 |
Intervention period n = 731 |
P valuea | OR (95% CI)b | ARR (95% CI)c | |
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| Microbiologically documented infection | ||||||
| Total population (n = 1416, 685/731)d | 478 (33.8) | 193 (28.2) | 285 (39.0) | <0.001 | – | – |
| Severe sepsis (n = 907, 442/465) | 322 (35.5) | 124 (28.1) | 198 (42.6) | <0.001 | 1.89 (1.43–2.50) | 14.5 (8.4–20.7) |
| Febrile neutropenia (n = 440, 222/218) | 137 (31.1) | 67 (30.2) | 70 (32.1) | 0.66 | 1.08 (0.71–1.64) | – |
| Suspicion of endocarditis (n = 69, 21/48) | 19 (27.5) | 2 (9.5) | 17 (35.4) | 0.04 | 6.22 (0.98–39.6) | 25.9 (7.4–44.4) |
| Secondary outcomes | ||||||
| Pathogens identifiede (n = 1416, 685/731) | ||||||
| Gram-negative bacillif | 192 (13.6) | 67 (9.8) | 125 (17.1) | <0.001 | 1.88 (1.36–2.59) | 7.32 (3.8–10.84) |
| Gram-positive coccif | 288 (20.3) | 124 (18.1) | 164 (22.4) | 0.04 | 1.32 (1.01–1.72) | 4.33 (0.16–8.51) |
| Fungi (Candida or Aspergillus)f | 21 (1.5) | 4 (0.6) | 17 (2.3) | 0.007 | 4.12 (1.38–12.36) | 1.74 (0.51–2.97) |
| Not included in the molecular test (anaerobes or other bacteria)f | 28 (2) | 10 (1.5) | 18 (2.5) | 0.18 | 1.69 (0.77–3.70) | – |
| Time (h) to result validation | ||||||
| Total population (n = 478, 193/285) | 23.6 (14.9–32) | 27.5 (20.8–50.9) | 22.1 (10.8–27.3) | 0.006 | ||
| Severe sepsis (n = 322, 124/198) | 23.2 (14.2–29.3) | 27.4 (19.2–57.0) | 21.6 (10.3–26.3) | <0.001 | ||
| Febrile neutropenia (n = 137, 67/70) | 28.5 (19.8–41.8) | 31.5 (21–48.3) | 26.8 (19.5–36.2) | 0.97 | ||
| Time (h) to result transmission | ||||||
| Total population (n = 478, 193/285) | 27.5 (17.3–62) | 48 (26.3–102) | 23.1 (13.2–36.2) | <0.001 | ||
| Severe sepsis (n = 322, 124/198) | 26 (16.9–59.4) | 49.5 (23.6–116) | 22.9 (12.5–32) | <0.001 | ||
| Febrile neutropenia (n = 137, 67/70) | 38.2 (25.3–67.5) | 54.8 (32.1–71.3) | 30.8 (21–40.9) | 0.15 | ||
| Appropriate antimicrobial treatment with regard to the bacteremia (n = 1375, 666/709) | 395 (28.7) | 157 (23.6) | 238 (33.6) | <0.0001 | 1.63 (1.29–2.07) |
Control period is standard care and intervention period is the period when molecular detection was added to standard care. (/) indicates the number of patients in each group. Variables are expressed as number (%)
OR odds ratios; CI confidence interval; ARR absolute risk reduction
a P value of the χ 2 or the Fisher’s exact test as appropriate, and of linear mixed-effects model for time to result validation and transmission, adjusted for order of intervention (study period first or second)
bORs (95% CI) were estimated using a random-center effect logistic regression adjusted for order of intervention (study period first or second)
cAbsolute risk reduction (ARR) was calculated from percentage values
dOR and ARR were not estimated among the total population because of significant effect modification by type of severe infection (P = 0.03)
eNumber of patients with at least the detailed pathogen isolated from blood
fFor details, see Table 4