Procalcitonin algorithm to guide initial antibiotic therapy in acute exacerbations of COPD admitted to the ICU: a randomized multicenter study
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 e...
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| Published in | Intensive care medicine Vol. 44; no. 4; pp. 428 - 437 |
|---|---|
| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.04.2018
Springer Springer Nature B.V Springer Verlag |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0342-4642 1432-1238 1432-1238 |
| DOI | 10.1007/s00134-018-5141-9 |
Cover
| 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. |
|---|---|
| AbstractList | 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).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).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%.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%.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).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).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.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. 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. 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). 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%. 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). 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. 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). 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%. 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). 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. 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. 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. |
| Audience | Academic |
| Author | Labbe, Vincent Terzi, Nicolas Mira, Jean-Paul Thiollière, Fabrice Annane, Djillali Daubin, Cédric Hazera, Pascal Parienti, Jean-Jacques Floccard, Bernard Valette, Xavier Du Cheyron, Damien Fournel, François |
| Author_xml | – sequence: 1 givenname: Cédric orcidid: 0000-0002-3898-6296 surname: Daubin fullname: Daubin, Cédric email: daubin-c@chu-caen.fr organization: Department of Medical Intensive Care, CHU de Caen – sequence: 2 givenname: Xavier surname: Valette fullname: Valette, Xavier organization: Department of Medical Intensive Care, CHU de Caen – sequence: 3 givenname: Fabrice surname: Thiollière fullname: Thiollière, Fabrice organization: Intensive Care Unit, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon – sequence: 4 givenname: Jean-Paul surname: Mira fullname: Mira, Jean-Paul organization: Department of Medial Intensive Care, Cochin University Hospital – sequence: 5 givenname: Pascal surname: Hazera fullname: Hazera, Pascal organization: Department of Intensive Care Medicine, General Hospital – sequence: 6 givenname: Djillali surname: Annane fullname: Annane, Djillali organization: Service de Médecine Intensive et Réanimation, Hôpital Raymond Poincaré (APHP), Laboratoire Infection and Inflammation, U1173 Université de Versailles SQY-Paris Saclay—INSERM – sequence: 7 givenname: Vincent surname: Labbe fullname: Labbe, Vincent organization: Service de Réanimation et USC Médico-chirurgicale, AP-HP, Hôpitaux Universitaires de l’Est Parisien, Hôpital Tenon – sequence: 8 givenname: Bernard surname: Floccard fullname: Floccard, Bernard organization: Department of Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon – sequence: 9 givenname: François surname: Fournel fullname: Fournel, François organization: Department of Biostatistics and Clinical Research, CHU de Caen – sequence: 10 givenname: Nicolas surname: Terzi fullname: Terzi, Nicolas organization: Department of Medical Intensive Care, CHU de Grenoble Alpes, INSERM, U1042, University of Grenoble-Alpes, HP2 – sequence: 11 givenname: Damien surname: Du Cheyron fullname: Du Cheyron, Damien organization: Department of Medical Intensive Care, CHU de Caen – sequence: 12 givenname: Jean-Jacques surname: Parienti fullname: Parienti, Jean-Jacques organization: Department of Biostatistics and Clinical Research, CHU de Caen, EA2656 Groupe de Recherche sur l’Adaptation Microbienne (GRAM 2.0), Université Caen Normandie |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29663044$$D View this record in MEDLINE/PubMed https://normandie-univ.hal.science/hal-02155549$$DView record in HAL |
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| ContentType | Journal Article |
| Contributor | Cédric, Daubin Vincent, Labbe Djillali, Annane Amélie, Seguin Julien, Bohe Jennifer, Brunet Xavier, Valette Olivier, Cabon Damien, Du Cheyron Bernard, Floccard Muriel, Fartoukh Jean-Paul, Mira Andréa, Polito Fabrice, Thiollière Bertrand, Sauneuf Mehdi, Bousta Fabrice, Daviaud Pierre, Charbonneau Michel, Ramakers Pascal, Hazera Jean-Philippe, Rigaud |
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| Copyright | The Author(s) 2018 COPYRIGHT 2018 Springer Intensive Care Medicine is a copyright of Springer, (2018). All Rights Reserved. Distributed under a Creative Commons Attribution 4.0 International License |
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| DOI | 10.1007/s00134-018-5141-9 |
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| Issue | 4 |
| Keywords | Chronic obstructive pulmonary disease Respiratory tract infection Community-acquired pneumonia Antibiotic stewardship Viral infection Procalcitonin |
| Language | English |
| License | Distributed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. cc-by-nc |
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| PublicationTitle | Intensive care medicine |
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Crit Care. 2013 Dec 11;17 (6):R291 |
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To compare the efficacy of an antibiotic protocol guided by serum procalcitonin (PCT) with that of standard antibiotic therapy in severe acute... To compare the efficacy of an antibiotic protocol guided by serum procalcitonin (PCT) with that of standard antibiotic therapy in severe acute exacerbations of... Purpose To compare the efficacy of an antibiotic protocol guided by serum procalcitonin (PCT) with that of standard antibiotic therapy in severe acute... PurposeTo compare the efficacy of an antibiotic protocol guided by serum procalcitonin (PCT) with that of standard antibiotic therapy in severe acute... |
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| SubjectTerms | Acute Disease Aged Algorithms Anesthesiology Anti-Bacterial Agents - therapeutic use Antibiotics Bacterial Infections - blood Bacterial Infections - complications Bacterial Infections - drug therapy Bacterial Infections - mortality Bacteriology Biomarkers - blood Care and treatment Chronic obstructive pulmonary disease Clinical Protocols Clinical trials Critical Care Medicine Drug administration Ecology, environment Emergency Medicine Evidence-based medicine Female France Health Health aspects Humans Intensive Intensive care Intensive Care Units Life Sciences Lung diseases, Obstructive Male Medicine Medicine & Public Health Microbiology and Parasitology Middle Aged Mortality Mycology Pain Medicine Patients Pediatrics Pneumology/Respiratory System Procalcitonin Procalcitonin - blood Prospective Studies Protistology Pulmonary Disease, Chronic Obstructive - blood Pulmonary Disease, Chronic Obstructive - drug therapy Pulmonary Disease, Chronic Obstructive - etiology Pulmonary Disease, Chronic Obstructive - mortality Seven-Day Profile Publication Therapy |
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| Title | Procalcitonin algorithm to guide initial antibiotic therapy in acute exacerbations of COPD admitted to the ICU: a randomized multicenter study |
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