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Comparison of Two Antibiotic Regimen (Meropenem Versus Meropenem+Moxifloxacin)in the Treatment of Severe Sepsis and Septic Shock (MaxSep)

Primary Purpose

Severe Sepsis, Septic Shock

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
meropenem
meropenem, moxifloxacin
Sponsored by
Kompetenznetz Sepsis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring sepsis, antibiotics, carbapenems, fluoroquinolones, Severe sepsis and septic shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • University Hospital Aachen - Dep. of Anesthesiology
  • Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
  • Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine
  • Charité Berlin - Dep. of Medicine (Cardiology, Angiology, Pneumology)
  • Charité Campus Mitte -Dep.of Infectiology and Pneumonology
  • Charité Campus Benjamin Franklin - Dep. of Medicine IV
  • Vivantes Klinikum Neukölln - Cardiology
  • Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
  • Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
  • Ev. Krankenhaus Gilead I - Dep. of Anesthesiology and Intensive Care Medicine
  • University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine
  • Städtisches Klinikum Brandenburg - Intensive Care Unit
  • Klinikum Darmstadt - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
  • Klinikum Dessau - Dep. of Medicine
  • Hospital Lippe-Detmold - Dep. of Anesthesiology and Intensive Care Medicine
  • Krankenhaus Dresden-Friedrichstadt
  • University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med.
  • HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine
  • University Erlangen-Nürnberg - Dep. of Medicine IV
  • University Hospital Freiburg - Dep. of Medicine III
  • Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine
  • Ernst-Moritz-Arndt-Universität Greifswald, Dep. of Internal Medicine B
  • Klinik am Eichert - Dep. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
  • Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine
  • Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology and Intensive Care Medicine
  • Hospital Martha-Maria Halle-Dölau gGmbH - Dep. of Anesthesiology and Intensive Care Medicine
  • Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine
  • Klinikum Hannover Nordstadt - Dep. of Anesthesiology and Intensive Care Medicine
  • Medizinische Hochschule Hannover, Dep. of Internal Medicine/ Pneumology
  • University Hospital Heidelberg - Dep. of Medicine IV
  • University Hospital Heidelberg - Dep. of Visceral and Transplantation Surgery
  • Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine
  • University Hospital Saarland - Deop. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
  • University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine
  • University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine
  • University Hospital Köln - Dep. of Internal Medicine I
  • Hospital Merheim - Dep. of Anesthesiology and Intensive Care Medicine
  • University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine
  • Hospital Ludwigshafen am Rhein - Dep. of Cardiac Surgery
  • Klinikum Lüdenscheid - Dep. of Anesthesiology
  • University Hospital Mannheim - Dep. of Medicine I
  • University Hospital Munich - Dep. of Internal Medicine
  • Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention
  • Klinikum rechts der Isar - Dep. of Anesthesiology
  • University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine
  • Klinikum Oldenburg - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine, Pain Therapy
  • Klinikum Ernst von Bergmann - Dep. of Anesthesiology and Intensive Care Medicine
  • University Hospital Rostock - Dep. of Anesthesiology and Intensive Care Medicine
  • Ev. Jung-Stilling-Krankenhaus - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine
  • University Hospital Tübingen - Dep. of Medicine
  • University Hospital Ulm - Dep. of Internal Medicine II
  • Stiftung Juliusspital Würzburg - Dep. of Medicine (Cardiology)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MeroMono

MeroMoxi

Arm Description

Monotherapy with meropenem

Combination therapy with meropenem + moxifloxacin

Outcomes

Primary Outcome Measures

Mean total SOFA score

Secondary Outcome Measures

Mortality
ICU and hospital length of stay
Response to therapy
Clinical and microbiological cure
Frequency of adverse events (AEs, SAEs, SUSARs)
Ventilator free days
Days without renal replacement therapy
Vasopressor free days
SOFA-subscores
Antibiotics free days
Costs of antibiotic therapy
Frequency of resistances to antibiotics
Frequency of new infections

Full Information

First Posted
September 21, 2007
Last Updated
June 28, 2012
Sponsor
Kompetenznetz Sepsis
Collaborators
AstraZeneca, Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00534287
Brief Title
Comparison of Two Antibiotic Regimen (Meropenem Versus Meropenem+Moxifloxacin)in the Treatment of Severe Sepsis and Septic Shock
Acronym
MaxSep
Official Title
Prospective, Randomized, Open, Multicentre Study About the Effect of an Empirical Antibiotic Monotherapy With Meropenem (Meronem®) Versus a Combination Therapy With Moxifloxacin (Avalox®) on Organ Dysfunction in Patients With Severe Sepsis and Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kompetenznetz Sepsis
Collaborators
AstraZeneca, Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
sepsis, antibiotics, carbapenems, fluoroquinolones, Severe sepsis and septic shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MeroMono
Arm Type
Active Comparator
Arm Description
Monotherapy with meropenem
Arm Title
MeroMoxi
Arm Type
Active Comparator
Arm Description
Combination therapy with meropenem + moxifloxacin
Intervention Type
Drug
Intervention Name(s)
meropenem
Other Intervention Name(s)
Meronem® (meropenem)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
meropenem, moxifloxacin
Other Intervention Name(s)
Meronem® (meropenem), Avalox® (moxifloxacin)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean total SOFA score
Time Frame
study duration but not longer than 14 days
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
28 and 90 days
Title
ICU and hospital length of stay
Title
Response to therapy
Time Frame
day 7 and day 10
Title
Clinical and microbiological cure
Time Frame
End of study therapy (day 7-14) and release from ICU (max. day 21)
Title
Frequency of adverse events (AEs, SAEs, SUSARs)
Title
Ventilator free days
Time Frame
28 and 90 days
Title
Days without renal replacement therapy
Time Frame
28 and 90 days
Title
Vasopressor free days
Time Frame
28 and 90 days
Title
SOFA-subscores
Title
Antibiotics free days
Time Frame
28 and 90 days
Title
Costs of antibiotic therapy
Time Frame
ICU stay
Title
Frequency of resistances to antibiotics
Time Frame
ICU stay
Title
Frequency of new infections

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Reinhart, MD
Organizational Affiliation
University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Markus Löffler, MD
Organizational Affiliation
University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Deufel, MD
Organizational Affiliation
University Hopitel Jena, Institute for Medical Chemistry
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Aachen - Dep. of Anesthesiology
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Berlin - Dep. of Medicine (Cardiology, Angiology, Pneumology)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Campus Mitte -Dep.of Infectiology and Pneumonology
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Campus Benjamin Franklin - Dep. of Medicine IV
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Vivantes Klinikum Neukölln - Cardiology
City
Berlin
ZIP/Postal Code
12313
Country
Germany
Facility Name
Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
City
Berlin
ZIP/Postal Code
12313
Country
Germany
Facility Name
Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Ev. Krankenhaus Gilead I - Dep. of Anesthesiology and Intensive Care Medicine
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Städtisches Klinikum Brandenburg - Intensive Care Unit
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany
Facility Name
Klinikum Darmstadt - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Klinikum Dessau - Dep. of Medicine
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Hospital Lippe-Detmold - Dep. of Anesthesiology and Intensive Care Medicine
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Krankenhaus Dresden-Friedrichstadt
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med.
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
University Erlangen-Nürnberg - Dep. of Medicine IV
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University Hospital Freiburg - Dep. of Medicine III
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität Greifswald, Dep. of Internal Medicine B
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Klinik am Eichert - Dep. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
City
Göppingen
ZIP/Postal Code
73035
Country
Germany
Facility Name
Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology and Intensive Care Medicine
City
Halle
ZIP/Postal Code
06097
Country
Germany
Facility Name
Hospital Martha-Maria Halle-Dölau gGmbH - Dep. of Anesthesiology and Intensive Care Medicine
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Klinikum Hannover Nordstadt - Dep. of Anesthesiology and Intensive Care Medicine
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Dep. of Internal Medicine/ Pneumology
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Hospital Heidelberg - Dep. of Medicine IV
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Hospital Heidelberg - Dep. of Visceral and Transplantation Surgery
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine
City
Heide
ZIP/Postal Code
25746
Country
Germany
Facility Name
University Hospital Saarland - Deop. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
University Hospital Köln - Dep. of Internal Medicine I
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Hospital Merheim - Dep. of Anesthesiology and Intensive Care Medicine
City
Köln
ZIP/Postal Code
51109
Country
Germany
Facility Name
University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Hospital Ludwigshafen am Rhein - Dep. of Cardiac Surgery
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinikum Lüdenscheid - Dep. of Anesthesiology
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
University Hospital Mannheim - Dep. of Medicine I
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
University Hospital Munich - Dep. of Internal Medicine
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention
City
Munich
ZIP/Postal Code
81545
Country
Germany
Facility Name
Klinikum rechts der Isar - Dep. of Anesthesiology
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum Oldenburg - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine, Pain Therapy
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Klinikum Ernst von Bergmann - Dep. of Anesthesiology and Intensive Care Medicine
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
University Hospital Rostock - Dep. of Anesthesiology and Intensive Care Medicine
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Ev. Jung-Stilling-Krankenhaus - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine
City
Siegen
ZIP/Postal Code
57074
Country
Germany
Facility Name
University Hospital Tübingen - Dep. of Medicine
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University Hospital Ulm - Dep. of Internal Medicine II
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Stiftung Juliusspital Würzburg - Dep. of Medicine (Cardiology)
City
Würzburg
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
1597042
Citation
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.
Results Reference
background
PubMed Identifier
17051663
Citation
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.
Results Reference
background
PubMed Identifier
15542958
Citation
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.
Results Reference
background
PubMed Identifier
14599631
Citation
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.
Results Reference
background
PubMed Identifier
15288826
Citation
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.
Results Reference
background
PubMed Identifier
17323051
Citation
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.
Results Reference
background
PubMed Identifier
20336279
Citation
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.
Results Reference
background
PubMed Identifier
22692171
Citation
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.
Results Reference
result
Links:
URL
http://www.sepsis-gesellschaft.de/DSG/Deutsch/SepNet?sid=nbGlH39rI6b9u2fBVVhxiM&iid=1
Description
Competence Network Sepsis (SepNet)
URL
http://www.sepsis-gesellschaft.de/
Description
German Sepsis Society

Learn more about this trial

Comparison of Two Antibiotic Regimen (Meropenem Versus Meropenem+Moxifloxacin)in the Treatment of Severe Sepsis and Septic Shock

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