Procalcitonin algorithm to guide initial antibiotic therapy in acute exacerbations of COPD admitted to the ICU: a randomized multicenter study |
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| Authors: | Cédric Daubin Xavier Valette Fabrice Thiollière Jean-Paul Mira Pascal Hazera Djillali Annane Vincent Labbe Bernard Floccard François Fournel Nicolas Terzi Damien Du Cheyron Jean-Jacques Parienti for the BPCTrea Study Group |
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| Institution: | 1.Department of Medical Intensive Care,CHU de Caen,Caen,France;2.Intensive Care Unit, Centre Hospitalier Lyon Sud,Hospices Civils de Lyon,Pierre Bénite,France;3.Department of Medial Intensive Care,Cochin University Hospital,Paris,France;4.Department of Intensive Care Medicine,General Hospital,Saint L?,France;5.Service de Médecine Intensive et Réanimation,H?pital Raymond Poincaré (APHP),Garches,France;6.Laboratoire Infection and Inflammation,U1173 Université de Versailles SQY-Paris Saclay—INSERM,Paris,France;7.Service de Réanimation et USC Médico-chirurgicale,AP-HP, H?pitaux Universitaires de l’Est Parisien, H?pital Tenon,Paris,France;8.Department of Anesthesiology and Critical Care Medicine,Edouard Herriot Hospital, Hospices Civils de Lyon,Lyon,France;9.Department of Biostatistics and Clinical Research,CHU de Caen,Caen,France;10.Department of Medical Intensive Care,CHU de Grenoble Alpes,Grenoble,France;11.INSERM, U1042, University of Grenoble-Alpes, HP2,Grenoble,France;12.EA2656 Groupe de Recherche sur l’Adaptation Microbienne (GRAM 2.0),Université Caen Normandie,Caen,France |
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| 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. |
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