Study/year | Trial design | Population | Type of ICU | N PCT/Ctrl | PCT-guided group protocol | Control group protocol | PCT assay |
---|---|---|---|---|---|---|---|
Svoboda et al. [30] | SC, P, R, OL | Postoperative severe sepsis | Surgical | 38/34 | AI: prompted change of ABT and catheter (≥ 2 ng/ml), prompted to repeated radiographic and/or surgical evaluation (< 2 ng/ml) | Standard evaluation by consultant surgeon | PCT-Q |
Schroeder et al. [31] | SC, P, R, OL | Postoperative severe sepsis | Surgical | 14/13 | AD: if clinic signs and symptoms improved and PCT < 1 ng/ml or 25–35% of baseline | According to clinical signs and empiric rules | LIA |
Nobre et al. [32] | SC, P, R, OL | Sepsis | Mixed | 39/40 | AD: if baseline PCT > 1 μg/L, re-evaluation at day 5. ABT discontinuation if PCT < 0.25 μg/L or PCT dropped by > 90% from the baseline peak level. If baseline PCT < 1 μg/L, re-evaluation at day 3. ABT discontinuation if PCT < 0.1 μg/L and careful clinical evaluation | Regimens according to guidelines | Kryptor |
Hochreiter et al. [33] | SC, P, R, OL | Infection | Surgical | 53/57 | AD: if clinic signs and symptoms improved and PCT < 1 ng/ml or 25–35% of initial value over 3 days | Standard regimen over 8 days | LIA |
Stolz et al. [34] | MC, P, R, OL | Ventilator-associated pneumonia | Mixed | 51/50 | AD: strongly encouraged (< 0.25 μg/L), encouraged (0.25–0.5 μg/L or a decrease ≥ 80%), discouraged (0.5–1.0 μg/L or a decrease < 80%) or strongly discouraged (> 1.0 μg/L) | According to clinical signs and empiric rules | Kryptor |
Bouadma et al. [35] | MC, P, R, OL | Bacterial infection or sepsis | Mixed | 311/319 | AI: ABT was strongly discouraged (< 0.25 μg/L), discouraged (0.25–0.49 μg/L), encouraged (0.5–0.99 μg/L) or strongly encouraged (≥ 1 μg/L) AD: strongly encouraged (< 0.25 μg/L), encouraged (0.25–0.49 μg/L). continuing of ABT was encouraged (0.25–0.5 μg/L or > 80% peak) and change of ABT (> peak concentration and > 0.5 μg/L) | Regimens according to international and local guidelines | Kryptor |
Jensen et al. [13] | MC, P, R, OL | Severe sepsis/septic shock | Mixed | 212/247 | AI: if PCT ≥ 1 μg/L that was not decreasing by at least 10% from previous day: increasing the antimicrobial spectrum and intensifying diagnostic efforts to find uncontrolled sources of infection | According to current guidelines | Kryptor |
Layios et al. [36] | SC, P, R, OL | Infection | Mixed | 258/251 | AI: ABT was strongly discouraged (< 0.25 μg/L), discouraged (0.25–0.5 μg/L), encouraged (0.5–1.0 μg/L) or strongly encouraged (> 1.0 μg/L) | No reports | Kryptor |
Annane et al. [38] | MC, P, R, OL | Septic shock | Mixed | 31/31 | AI/AD: ABT was not to be started or was to be discontinuation (< 0.25 μg/L); strongly discouraged (≥ 0.25 to < 0.5 μg/L); was recommended (≥ 0.5 to < 5 μg/L) and was strongly recommended (≥ 5 μg/L). For patients enrolled ≤ 48 h after surgery, the respective PCT cut-offs were < 4 μg/L, 4–9 μg/L and ≥ 9 μg/L | ABT at the discretion of the patient’s physician | Kryptor |
Deliberato et al. [39] | SC, P, R, OL | Sepsis | Mixed | 42/39 | AD: if PCT dropped > 90% from the peak level or the absolute value < 0.5 ng/ml | The possible source of infection and local susceptibility profile | Vidas |
Shehabi et al. [23] | MC, P, R, SB | Bacterial infection or sepsis | Mixed | 200/200 | AD: cease ABT when PCT < 0.1 ng/ml or PCT was 0.1–0.25 ng/ml and infection is highly unlikely or PCT level decreased > 90% from baseline | According to the ABT guidelines | Automated immunoassay analysers |
De Jong et al. [24] | MC, P, R, OL | Infection | Mixed | 776/799 | AD: if PCT value decreased over 80% or PCT value lower than 0.5 μg/L | Guidelines and the discretion of attending physicians | Vidas, Roche or Kryptor machine |
Bloos et al. [37] | MC, P, R, OL | Severe sepsis/septic shock | Mixed | 587/593 | AD: stopping ABT if PCT level on day 7 or later < 1 ng/ml r or dropped > 50% from the previous value | According to the local sepsis guidelines | Kryptor |