Table 2. Summary of characteristics of RCTs assessing PCT-guided antibiotic stewardship in adult critical care patients.
| Study | Setting | Duration of study (months) | PCT assay | N total (PCT/control) | Rate of exclusion, n [%] | Decision not to start AB, PCT/control [%] | Duration AB therapy, PCT/control [days] | Overruling PCT algorithm [%] | 28-day mortality, PCT/control, n [%] |
|---|---|---|---|---|---|---|---|---|---|
| SAPS, Jong 2016 (36) | 15 ICU (Netherlands) | 58 | TRACE | 1,575 (776/799) | 2,932 [65] | – | 5 [3–9]/7 [4–11], P<0.0001 | 66 | 149 [19.6]/196 [25], P=0.0122 |
| ProGUARD, Shehabi 2014 (39) | 11 mixed ICU (Australia) | 29 | TRACE | 394 (196/198) | 1,167 [74] | – | 9 [6–21]/11 [6–22] | 3 | 21 [11]/15 [8] |
| Annane 2013 (40) | 8 mixed ICU (France) | 36 | TRACE | 58 (30/28) | 1,158 [92] | 4 [15]/4 [15]† | 5 [2–5]/5 [3–5] | 37 | 7 [23]/10 [33] |
| Deliberato 2013 (41) | Mixed ICU (Brazil) | 24 | PCT LIA | 81 (42/39) | 184 [69] | – | 10 [3–39]/11 [2–45] | 29 | 2 [2.4]/4 [10.3] |
| Layios 2012 (32) | 5 mixed ICU (Belgium) | 9 | TRACE | 509 (258/251) | 992 [66] | 26 [7.6]/21 [6.7]‡ | 147.3±206/141.1±136.9, (DDD/100 ICU days) | 34.6 | 56 [21.7]/53 [21.1] |
| PASS, Jensen 2011 (34) | 9 ICU (Denmark) | 29 | TRACE | 1,200 (604/596) | 3 [0.3] | 56 [18]/37 [17.6]§ | 6 [3–11]/4 [3–10] | 17.9 | 190 [31.5]/191 [32] |
| PRORATA, Bouadma 2010 (33) | 7 ICU (5 medical, 2 surgical) (France) | 12 | TRACE | 601 (307/314) | 685 [52] | 27 [9]/7 [2]† | 10.3±7.7/13.3±7.6, P<0.0001 | 53 | 65 [21.2]/64 [20.4] |
| ProSICU, Hochreiter 2009 (42) | Surgical ICU (Germany) | 15 | PCT LIA | 110 (57/53) | 285 [72] | – | 5.9±1.7/7.9±0.5, P<0.001 | 15 [26.3]/14 [26.4] | |
| ProVAP, Stolz 2009 (43) | 7 mixed ICU (USA and Switzerland) | 30 | TRACE | 101 (51/50) | 63 [38] | – | 10 [6–16]/15 [10–23], P=0.038 | 16 | 8 [16]/12 [24] |
| Schroeder 2009 (44) | Surgical ICU (Germany) | 7 | PCT LIA | 27 (14/13) | 98 [78] | – | 6.6±1.1/8.3±0.7, P<0.001 | 3 [21.4]/3 [23.1] | |
| ProSEP, Nobre 2008 (45) | Mixed ICU (Switzerland) | 15 | TRACE | 79 (39/40) | 203 [72] | – | 6 [4–16]/10 [3–33], P=0.003 | 19 | 8 [20.5]/8 [20] |
| Svoboda 2007 (46) | Surgical ICU (Czech Republic) | 29 | PCT-Q | 72 (38/34) | 381 [84] | – | 9/13 | 29 | 10 [26]/13 [38] |
†, number of patients who did not receive antibiotics for the entire study; ‡, number of patients in whom clinical confidence of infection was uncertain; §, number of patients with baseline “alert PCT” in PCT group who did not receive antibiotics at enrollment/number of patients in the control group who were judged to have infection but did not receive antibiotics at enrollment; DDD, defined daily dose; PCT, procalcitonin; RCT, randomized-controlled trial; ICU, intensive care units; TRACE, time-resolved amplified cryptate emission.