C Putensen1, B Ellger2, S G Sakka3, A Weyland4, K Schmidt5, M Zoller6, N Weiler7, D Kindgen-Milles8, U Jaschinski9, J Weile10, S Lindau11, M Kieninger12, A Faltlhauser13, N Jung14, P Teschendorf15, M Adamzik16, M Gründling17, T Wahlers18, H Gerlach19, F-A Litty20. 1. Department of Anesthesiology and Surgical Intensive Care Medicine, Medical School of the University of Bonn, Bonn, Germany. 2. Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, Klinikum Westfalen GmbH, Dortmund, Germany. 3. Department of Anesthesiology and Operative Intensive Care Medicine, Medical Center Cologne-Merheim, University of Witten/Herdecke, Cologne, Germany. 4. Department of Anesthesiology/Intensive Care Medicine/Emergency Medicine/Pain Therapy, Klinikum Oldenburg GmbH, Oldenburg, Germany. 5. Department of Anesthesiology, Charité University Hospital Berlin, Berlin, Germany. 6. Department of Anesthesiology, University Hospital Munich, Munich, Germany. 7. Department of Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig- Holstein, Campus Kiel, Kiel, Germany. 8. Department of Anesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany. 9. Department of Anesthesiology and Surgical Intensive Care Medicine, University Hospital Augsburg, Augsburg, Germany. 10. Department of Thorax and Cardiovascular Medicine, Institute of Laboratory and Transfusion Medicine, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany. 11. Department of Anesthesiology/Intensive Care Medicine/Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany. 12. Department of Anesthesiology and Neurosurgical Intensive Care Unit, University Hospital Regensburg, Regensburg, Germany. 13. Interdisciplinary Intensive Care Unit, Weiden Hospital, Weiden, Germany. 14. Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany. 15. Department of Anesthesiology and Surgical Intensive Care Medicine, Klinikum Osnabrück GmbH, Osnabrück, Germany. 16. Department of Anesthesiology/Intensive Care Medicine/Pain Therapy, Knappschaftskrankenhaus Bochum, Bochum, Germany. 17. Department of Anesthesiology/Intensive Care Medicine/Emergency Medicine/Pain Therapy, University Hospital Greifswald, Greifswald, Germany. 18. Department of Cardiothoracic Surgery, University Hospital of Cologne, Cologne, Germany. 19. Department of Anesthesiology and Surgical Intensive Care Medicine, Klinikum Neukölln, Berlin, Germany. 20. InfectoPharm Arzneimittel und Consilium GmbH, Heppenheim, Germany. felix-alexander.litty@infectopharm.com.
Abstract
PURPOSE: In Europe, intravenous fosfomycin (IV) is used particularly in difficult-to-treat or complex infections, caused by both Gram-positive and Gram-negative pathogens including multidrug-resistant strains. Here, we investigated the efficacy and safety of intravenous fosfomycin under real-life conditions. METHODS: Prospective, multi-center, and non-interventional study in patients with bacterial infections from 20 intensive care units (ICU) in Germany and Austria (NCT01173575). RESULTS: Overall, 209 patients were included (77 females, 132 males, mean age: 59 ± 16 years), 194 of which were treated in intensive care (APACHE II score at the beginning of fosfomycin therapy: 23 ± 8). Main indications (± bacteremia or sepsis) were infections of the CNS (21.5%), community- (CAP) and hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP, 15.3%), bone and joint infections (BJI, 11%), abdominal infections (11%), and bacteremia (10.5%). Most frequently identified pathogens were S. aureus (22.3%), S. epidermidis (14.2%), Enterococcus spp. (10.8%), E. coli (12.3%) and Klebsiella spp. (7.7%). At least one multidrug-resistant (MDR) pathogen was isolated from 51 patients (24.4%). Fosfomycin was administered with an average daily dose of 13.7 ± 3.5 g over 12.4 ± 8.6 days, almost exclusively (99%) in combination with other antibiotics. The overall clinical success was favorable in 81.3% (148/182) of cases, and in 84.8% (39/46) of patients with ≥ 1 MDR pathogen. Noteworthy, 16.3% (34/209) of patients developed at least one, in the majority of cases non-serious, adverse drug reaction during fosfomycin therapy. CONCLUSION: Our data suggest that IV fosfomycin is an effective and safe combination partner for the treatment of a broad spectrum of severe bacterial infections in critically ill patients.
PURPOSE: In Europe, intravenous fosfomycin (IV) is used particularly in difficult-to-treat or complex infections, caused by both Gram-positive and Gram-negative pathogens including multidrug-resistant strains. Here, we investigated the efficacy and safety of intravenous fosfomycin under real-life conditions. METHODS: Prospective, multi-center, and non-interventional study in patients with bacterial infections from 20 intensive care units (ICU) in Germany and Austria (NCT01173575). RESULTS: Overall, 209 patients were included (77 females, 132 males, mean age: 59 ± 16 years), 194 of which were treated in intensive care (APACHE II score at the beginning of fosfomycin therapy: 23 ± 8). Main indications (± bacteremia or sepsis) were infections of the CNS (21.5%), community- (CAP) and hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP, 15.3%), bone and joint infections (BJI, 11%), abdominal infections (11%), and bacteremia (10.5%). Most frequently identified pathogens were S. aureus (22.3%), S. epidermidis (14.2%), Enterococcus spp. (10.8%), E. coli (12.3%) and Klebsiella spp. (7.7%). At least one multidrug-resistant (MDR) pathogen was isolated from 51 patients (24.4%). Fosfomycin was administered with an average daily dose of 13.7 ± 3.5 g over 12.4 ± 8.6 days, almost exclusively (99%) in combination with other antibiotics. The overall clinical success was favorable in 81.3% (148/182) of cases, and in 84.8% (39/46) of patients with ≥ 1 MDR pathogen. Noteworthy, 16.3% (34/209) of patients developed at least one, in the majority of cases non-serious, adverse drug reaction during fosfomycin therapy. CONCLUSION: Our data suggest that IV fosfomycin is an effective and safe combination partner for the treatment of a broad spectrum of severe bacterial infections in critically illpatients.
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