Procalcitonin algorithm to guide initial antibiotic therapy in acute exacerbations of COPD admitted to the ICU: a randomized multicenter study

Abstract

PurposeTo compare the efficacy of an antibiotic protocol guided by serum procalcitonin (PCT) with that of standard antibiotic therapy in severe acute exacerbations of COPD (AECOPDs) admitted to the intensive care unit (ICU).MethodsWe conducted a multicenter, randomized trial in France. Patients experiencing severe AECOPDs were assigned to groups whose antibiotic therapy was guided by (1) a 5-day PCT algorithm with predefined cutoff values for the initiation or stoppage of antibiotics (PCT group) or (2) standard guidelines (control group). The primary endpoint was 3-month mortality. The predefined noninferiority margin was 12%.ResultsA total of 302 patients were randomized into the PCT (n = 151) and control (n = 151) groups. Thirty patients (20%) in the PCT group and 21 patients (14%) in the control group died within 3 months of admission (adjusted difference, 6.6%; 90% CI − 0.3 to 13.5%). Among patients without antibiotic therapy at baseline (n = 119), the use of PCT significantly increased 3-month mortality [19/61 (31%) vs. 7/58 (12%), p = 0.015]. The in-ICU and in-hospital antibiotic exposure durations, were similar between the PCT and control group (5.2 ± 6.5 days in the PCT group vs. 5.4 ± 4.4 days in the control group, p = 0.85 and 7.9 ± 8 days in the PCT group vs. 7.7 ± 5.7 days in the control group, p = 0.75, respectively).ConclusionThe PCT group failed to demonstrate non-inferiority with respect to 3-month mortality and failed to reduce in-ICU and in-hospital antibiotic exposure in AECOPDs admitted to the ICU.Electronic supplementary materialThe online version of this article (10.1007/s00134-018-5141-9) contains supplementary material, which is available to authorized users.

Procalcitonin (PCT)-guided antibiotic stewardship: an international experts consensus on optimized clinical use

“…Fourth, the BPCTrea study investigated a PCT algorithm to guide antibiotic treatment for COPD patients admitted to the ICU for ventilator support [34]. Although the 28-day mortality was similar for both the PCT and standard of care group, a higher 3-month mortality was observed for the PCT group.…”

“…Thus, the analytical sensitivity, as expressed by the functional sensitivity should be in this range to assure the accuracy of measurement at low PCT levels. In addition, the validation of the assay should assure that the accuracy (bias and imprecision) should be appropriate [34,35].…”

Diagnostic utility of procalcitonin in inpatients at a community hospital

“…As shown in Case 1, the use of procalcitonin to delay administration of antibiotics has not proven helpful in septic patients, and in some cases has proven harmful . Pretest probability of infection in this patient is high, and the negative procalcitonin is not convincing enough to delay antibiotic treatment.…”

Chronic Obstructive Pulmonary Disease in the Intensive Care Unit: Antibiotic Treatment of Severe Chronic Obstructive Pulmonary Disease Exacerbations

“…A total of 302 patients were randomized into the PCT (n ¼ 151) and control (n ¼ 151) group and followed for 3 months. 22 Results showed that the two groups were similar with regards to circulating PCT levels at study enrollment, 6 hour post-enrollment, and on days 1, 3, and 5. At 3 months after inclusion, 51 (17%) patients had died [30 (20%) in the PCT group and 21 (14%) in the control group; adjusted difference, 6.6%; 90% CI: À0.3 to 13.5%].…”

“…Daubin et al performed a multicenter, prospective, parallel-group, randomized control trial in the ICUs of 11 French hospitals. 22 Patients who had severe AECOPD with suspected lower respiratory tract infections with or without pneumonia, and who were admitted to the ICU, were eligible for the study. They were assigned in a 1:1 ratio to compare antibiotic therapy guided by (1) a PCT algorithm with predefined cutoff values for the initiation and discontinua-tion of antibiotics or (2) standard guidelines (control group).…”