Comparison of Two Antibiotic Regimen (Meropenem Versus Meropenem+Moxifloxacin)in the Treatment of Severe Sepsis and Septic Shock
- Conditions
- Severe SepsisSeptic Shock
- Interventions
- Registration Number
- NCT00534287
- Lead Sponsor
- Kompetenznetz Sepsis
- Brief Summary
Severe sepsis and septic shock are diseases of infectious origin with a high risk of death. Antibiotic therapy is mandatory but it is unknown whether one antibiotic alone is sufficient for initial therapy. The purpose of this study is to compare a therapy with meropenem alone or the combination of meropenem plus moxifloxacin in the treatment of severe sepsis/ septic shock. Patients randomly receive one of the two treatments for at least 7 days but not longer than 14 days.
- Detailed Description
Early intravenous empiric broad-spectrum antimicrobial therapy is an essential part of sepsis therapy. Inadequacy of empirical antibiotic therapy is associated with an increased mortality rate. Carbapenems are designed for empirical antimicrobial monotherapy. Combination therapy has been suggested but efficiency remains to be proven. In this study, antimicrobial monotherapy with meropenem is compared with a combination therapy of meropenem and moxifloxacin. It is hypothesized that the superior antibiotic therapy is associated with a lower overall organ dysfunction in sepsis. Study therapy lasts for at least 7 days unless microbiological results suggest otherwise. Study therapy may be extended to 14 days. Follow up examinations occur at 28 and 90 days. This investigator initiated study is supported by the German government (bmbf) and unrestricted industrial grants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- Severe sepsis or septic shock according to ACCP/SCCM criteria
- Onset of severe sepsis or septic shock <24 h
- Informed consent
- Effective contraception in fertile women
- Age <18 years
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MeroMono meropenem Monotherapy with meropenem MeroMoxi meropenem, moxifloxacin Combination therapy with meropenem + moxifloxacin
- Primary Outcome Measures
Name Time Method Mean total SOFA score study duration but not longer than 14 days
- Secondary Outcome Measures
Name Time Method Mortality 28 and 90 days ICU and hospital length of stay Response to therapy day 7 and day 10 Clinical and microbiological cure End of study therapy (day 7-14) and release from ICU (max. day 21) Frequency of adverse events (AEs, SAEs, SUSARs) Ventilator free days 28 and 90 days Days without renal replacement therapy 28 and 90 days Vasopressor free days 28 and 90 days SOFA-subscores Antibiotics free days 28 and 90 days Costs of antibiotic therapy ICU stay Frequency of resistances to antibiotics ICU stay Frequency of new infections
Trial Locations
- Locations (52)
Klinikum Oldenburg - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine, Pain Therapy
🇩🇪Oldenburg, Germany
University Hospital Ulm - Dep. of Internal Medicine II
🇩🇪Ulm, Germany
University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Münster, 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
Klinikum Ernst von Bergmann - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Potsdam, Germany
University Hospital Tübingen - Dep. of Medicine
🇩🇪Tübingen, Germany
Stiftung Juliusspital Würzburg - Dep. of Medicine (Cardiology)
🇩🇪Würzburg, Germany
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 Campus Benjamin Franklin - Dep. of Medicine IV
🇩🇪Berlin, Germany
Charité Campus Mitte -Dep.of Infectiology and Pneumonology
🇩🇪Berlin, Germany
Charité Berlin - Dep. of Medicine (Cardiology, Angiology, Pneumology)
🇩🇪Berlin, Germany
Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
🇩🇪Berlin, Germany
Vivantes Klinikum Neukölln - Cardiology
🇩🇪Berlin, Germany
University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Bonn, Germany
Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
🇩🇪Berlin, Germany
Ev. Krankenhaus Gilead I - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Bielefeld, Germany
Städtisches Klinikum Brandenburg - Intensive Care Unit
🇩🇪Brandenburg, 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 Erlangen-Nürnberg - Dep. of Medicine IV
🇩🇪Erlangen, 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 Hospital Freiburg - Dep. of Medicine III
🇩🇪Freiburg, Germany
Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine
🇩🇪Hamburg, 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
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
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
University Hospital Heidelberg - Dep. of Medicine IV
🇩🇪Heidelberg, Germany
University Hospital Saarland - Deop. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
🇩🇪Homburg/Saar, Germany
Hospital Merheim - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Köln, Germany
Klinikum Hannover Nordstadt - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Hannover, Germany
Medizinische Hochschule Hannover, Dep. of Internal Medicine/ Pneumology
🇩🇪Hannover, Germany
University Hospital Heidelberg - Dep. of Visceral and Transplantation Surgery
🇩🇪Heidelberg, Germany
University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Leipzig, Germany
Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Heide, 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 Köln - Dep. of Internal Medicine I
🇩🇪Köln, Germany
Klinikum Lüdenscheid - Dep. of Anesthesiology
🇩🇪Luedenscheid, Germany
Hospital Ludwigshafen am Rhein - Dep. of Cardiac Surgery
🇩🇪Ludwigshafen, Germany
Ev. Jung-Stilling-Krankenhaus - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine
🇩🇪Siegen, Germany
University Hospital Rostock - Dep. of Anesthesiology and Intensive Care Medicine
🇩🇪Rostock, Germany