Comparison of Two Antibiotic Regimen (Meropenem Versus Meropenem+Moxifloxacin)in the Treatment of Severe Sepsis and Septic Shock
NCT ID: NCT00534287
Last Updated: 2012-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2007-10-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MeroMono
Monotherapy with meropenem
meropenem
Empirical antibiotic therapy with 3 x 1 g intravenous meropenem. Dosage is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
MeroMoxi
Combination therapy with meropenem + moxifloxacin
meropenem, moxifloxacin
Empirical antibiotic therapy with 3 x 1 g intravenous meropenem plus 1 x 400 mg intravenous moxifloxacin. Dosage of meropenem is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
Interventions
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meropenem
Empirical antibiotic therapy with 3 x 1 g intravenous meropenem. Dosage is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
meropenem, moxifloxacin
Empirical antibiotic therapy with 3 x 1 g intravenous meropenem plus 1 x 400 mg intravenous moxifloxacin. Dosage of meropenem is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Onset of severe sepsis or septic shock \<24 h
* Informed consent
* Effective contraception in fertile women
Exclusion Criteria
* Pregnancy
* Breast-feeding women
* Pretreatment with meropenem, imipenem, or ertapenem within the last 4 weeks (\>1 daily dosage)
* Pretreatment with moxifloxacin,ciprofloxacin, or levofloxacin within the last 4 weeks (\>1 daily dosage)
* Pretreatment with a pseudomonas effective cephalosporin (cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (\>1 daily dosage).
* Pretreatment with other chinolones within the last 4 weeks (\>1 daily dosage)
* Presence of infection where guidelines recommend another antimicrobial therapy than the study medication (i.e. endocarditis)
* Evidence or strong clinical suspicion of a microorganism where the study medication is known to be ineffective (i.e. tuberculosis, MRSA- or VRE-infection)
* Known allergy against meropenem or moxifloxacin
* Tendon disease or injury due to past quinolone therapy
* Congenital or acquired prolongation of QT-interval
* Concomitant medication which prolongs the QT-interval
* Electrolyte imbalance, especially uncorrected hypokalemia
* Clinically relevant bradycardia
* Clinically relevant cardiac dysfunction with reduced left-ventricular ejection fraction
* Symptomatic arrhythmias in the medical history
* Significant hepatic impairment (Child-Pugh C) or elevation of liver enzymes \>5x the upper normal range
* No commitment to full patient support (i.e. DNR order)
* Patient's death is considered imminent due to coexisting disease
* Concomitant participation in another study or study participation with in the last 30 days.
* Relationship of the patient to study team member (i.e. colleague, relative)
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Bayer
INDUSTRY
Kompetenznetz Sepsis
NETWORK
Responsible Party
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Principal Investigators
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Konrad Reinhart, MD
Role: STUDY_CHAIR
University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine
Markus Löffler, MD
Role: STUDY_DIRECTOR
University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL)
Thomas Deufel, MD
Role: STUDY_DIRECTOR
University Hopitel Jena, Institute for Medical Chemistry
Locations
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University Hospital Aachen - Dep. of Anesthesiology
Aachen, , Germany
Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
Augsburg, , Germany
Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine
Berlin, , Germany
Charité Berlin - Dep. of Medicine (Cardiology, Angiology, Pneumology)
Berlin, , Germany
Charité Campus Mitte -Dep.of Infectiology and Pneumonology
Berlin, , Germany
Charité Campus Benjamin Franklin - Dep. of Medicine IV
Berlin, , Germany
Vivantes Klinikum Neukölln - Cardiology
Berlin, , Germany
Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Berlin, , Germany
Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
Berlin, , Germany
Ev. Krankenhaus Gilead I - Dep. of Anesthesiology and Intensive Care Medicine
Bielefeld, , Germany
University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine
Bonn, , Germany
Städtisches Klinikum Brandenburg - Intensive Care Unit
Brandenburg, , Germany
University Hospital Köln - Dep. of Internal Medicine I
Cologne, , Germany
Hospital Merheim - Dep. of Anesthesiology and Intensive Care Medicine
Cologne, , Germany
Klinikum Darmstadt - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Darmstadt, , Germany
Klinikum Dessau - Dep. of Medicine
Dessau, , Germany
Hospital Lippe-Detmold - Dep. of Anesthesiology and Intensive Care Medicine
Detmold, , Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, , Germany
University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med.
Dresden, , Germany
HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine
Erfurt, , Germany
University Erlangen-Nürnberg - Dep. of Medicine IV
Erlangen, , Germany
University Hospital Freiburg - Dep. of Medicine III
Freiburg im Breisgau, , Germany
Klinik am Eichert - Dep. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
Göppingen, , Germany
Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine
Göttingen, , Germany
Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine
Greifswald, , Germany
Ernst-Moritz-Arndt-Universität Greifswald, Dep. of Internal Medicine B
Greifswald, , Germany
Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology and Intensive Care Medicine
Halle, , Germany
Hospital Martha-Maria Halle-Dölau gGmbH - Dep. of Anesthesiology and Intensive Care Medicine
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine
Hamburg, , Germany
Klinikum Hannover Nordstadt - Dep. of Anesthesiology and Intensive Care Medicine
Hanover, , Germany
Medizinische Hochschule Hannover, Dep. of Internal Medicine/ Pneumology
Hanover, , Germany
Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine
Heide, , Germany
University Hospital Heidelberg - Dep. of Medicine IV
Heidelberg, , Germany
University Hospital Heidelberg - Dep. of Visceral and Transplantation Surgery
Heidelberg, , Germany
University Hospital Saarland - Deop. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
Homburg/Saar, , Germany
University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine
Jena, , Germany
University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine
Kiel, , Germany
University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine
Leipzig, , Germany
Hospital Ludwigshafen am Rhein - Dep. of Cardiac Surgery
Ludwigshafen, , Germany
Klinikum Lüdenscheid - Dep. of Anesthesiology
Lüdenscheid, , Germany
University Hospital Mannheim - Dep. of Medicine I
Mannheim, , Germany
University Hospital Munich - Dep. of Internal Medicine
Munich, , Germany
Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention
Munich, , Germany
Klinikum rechts der Isar - Dep. of Anesthesiology
Munich, , Germany
University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine
Münster, , Germany
Klinikum Oldenburg - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine, Pain Therapy
Oldenburg, , Germany
Klinikum Ernst von Bergmann - Dep. of Anesthesiology and Intensive Care Medicine
Potsdam, , Germany
University Hospital Rostock - Dep. of Anesthesiology and Intensive Care Medicine
Rostock, , Germany
Ev. Jung-Stilling-Krankenhaus - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine
Siegen, , Germany
University Hospital Tübingen - Dep. of Medicine
Tübingen, , Germany
University Hospital Ulm - Dep. of Internal Medicine II
Ulm, , Germany
Stiftung Juliusspital Würzburg - Dep. of Medicine (Cardiology)
Würzburg, , Germany
Countries
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References
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American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74.
Reinhart K, Brunkhorst F, Bone H, Gerlach H, Grundling M, Kreymann G, Kujath P, Marggraf G, Mayer K, Meier-Hellmann A, Peckelsen C, Putensen C, Quintel M, Ragaller M, Rossaint R, Stuber F, Weiler N, Welte T, Werdan K; Deutsche Sepsis-Gesellschaft e.V. [Diagnosis and therapy of sepsis: guidelines of the German Sepsis Society Inc. and the German Interdisciplinary Society for Intensive and Emergency Medicine]. Anaesthesist. 2006 Jun;55 Suppl 1:43-56. German.
Bochud PY, Bonten M, Marchetti O, Calandra T. Antimicrobial therapy for patients with severe sepsis and septic shock: an evidence-based review. Crit Care Med. 2004 Nov;32(11 Suppl):S495-512. doi: 10.1097/01.ccm.0000143118.41100.14.
Harbarth S, Garbino J, Pugin J, Romand JA, Lew D, Pittet D. Inappropriate initial antimicrobial therapy and its effect on survival in a clinical trial of immunomodulating therapy for severe sepsis. Am J Med. 2003 Nov;115(7):529-35. doi: 10.1016/j.amjmed.2003.07.005.
Safdar N, Handelsman J, Maki DG. Does combination antimicrobial therapy reduce mortality in Gram-negative bacteraemia? A meta-analysis. Lancet Infect Dis. 2004 Aug;4(8):519-27. doi: 10.1016/S1473-3099(04)01108-9.
Engel C, Brunkhorst FM, Bone HG, Brunkhorst R, Gerlach H, Grond S, Gruendling M, Huhle G, Jaschinski U, John S, Mayer K, Oppert M, Olthoff D, Quintel M, Ragaller M, Rossaint R, Stuber F, Weiler N, Welte T, Bogatsch H, Hartog C, Loeffler M, Reinhart K. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. 2007 Apr;33(4):606-18. doi: 10.1007/s00134-006-0517-7. Epub 2007 Feb 24.
Pletz MW, Bloos F, Burkhardt O, Brunkhorst FM, Bode-Boger SM, Martens-Lobenhoffer J, Greer MW, Stass H, Welte T. Pharmacokinetics of moxifloxacin in patients with severe sepsis or septic shock. Intensive Care Med. 2010 Jun;36(6):979-83. doi: 10.1007/s00134-010-1864-y. Epub 2010 Mar 25.
Brunkhorst FM, Oppert M, Marx G, Bloos F, Ludewig K, Putensen C, Nierhaus A, Jaschinski U, Meier-Hellmann A, Weyland A, Grundling M, Moerer O, Riessen R, Seibel A, Ragaller M, Buchler MW, John S, Bach F, Spies C, Reill L, Fritz H, Kiehntopf M, Kuhnt E, Bogatsch H, Engel C, Loeffler M, Kollef MH, Reinhart K, Welte T; German Study Group Competence Network Sepsis (SepNet). Effect of empirical treatment with moxifloxacin and meropenem vs meropenem on sepsis-related organ dysfunction in patients with severe sepsis: a randomized trial. JAMA. 2012 Jun 13;307(22):2390-9. doi: 10.1001/jama.2012.5833.
Related Links
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Competence Network Sepsis (SepNet)
German Sepsis Society
Other Identifiers
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bmbf grant: 01 KI 01 06
Identifier Type: -
Identifier Source: secondary_id
EudraCT 2006-006984-21
Identifier Type: -
Identifier Source: org_study_id