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Randomized Controlled Trial
. 2018 Apr;44(4):428-437.
doi: 10.1007/s00134-018-5141-9. Epub 2018 Apr 16.

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

Cédric Daubin  1 , Xavier Valette  2 , Fabrice Thiollière  3 , Jean-Paul Mira  4 , Pascal Hazera  5 , Djillali Annane  6   7 , Vincent Labbe  8 , Bernard Floccard  9 , François Fournel  10 , Nicolas Terzi  11   12 , Damien Du Cheyron  2 , Jean-Jacques Parienti  10   13 ; BPCTrea Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Cédric Daubin et al. Intensive Care Med. 2018 Apr.

Abstract

Purpose: To 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).

Methods: We 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%.

Results: A 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).

Conclusion: The 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.

Keywords: Antibiotic stewardship; Chronic obstructive pulmonary disease; Community-acquired pneumonia; Procalcitonin; Respiratory tract infection; Viral infection.

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Conflict of interest statement

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

The study protocol was approved by the local research ethic committee (Comité de Protection des Personnes Nord Ouest III) for all participating centres.

Informed consent

Written informed consent was obtained from the patients or their surrogates upon their enrolment in the study.

Figures

Fig. 1
Fig. 1
Flow chart. LRTI low respiratory tract infection
Fig. 2
Fig. 2
Effect of the PCT protocol on all-cause mortality
Fig. 3
Fig. 3
Patients receiving antibiotics during the PCT algorithm phase
Fig. 4
Fig. 4
Effect of the PCT protocol on in-ICU (a) and in-hospital (b) antibiotic treatment durations in the groups randomized according to the presence or absence of pneumonia
See this image and copyright information in PMC

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