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

June 28, 2012 updated by: Kompetenznetz Sepsis

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • University Hospital Aachen - Dep. of Anesthesiology
      • Augsburg, Germany, 86156
        • Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
      • Berlin, Germany, 10117
        • Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine
      • Berlin, Germany, 12313
        • Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
      • Berlin, Germany, 13353
        • Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
      • Berlin, Germany, 10117
        • Charité Berlin - Dep. of Medicine (Cardiology, Angiology, Pneumology)
      • Berlin, Germany, 10117
        • Charité Campus Mitte -Dep.of Infectiology and Pneumonology
      • Berlin, Germany, 12203
        • Charité Campus Benjamin Franklin - Dep. of Medicine IV
      • Berlin, Germany, 12313
        • Vivantes Klinikum Neukölln - Cardiology
      • Bielefeld, Germany, 33617
        • Ev. Krankenhaus Gilead I - Dep. of Anesthesiology and Intensive Care Medicine
      • Bonn, Germany, 53105
        • University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine
      • Brandenburg, Germany, 14770
        • Städtisches Klinikum Brandenburg - Intensive Care Unit
      • Darmstadt, Germany, 64283
        • Klinikum Darmstadt - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
      • Dessau, Germany, 06847
        • Klinikum Dessau - Dep. of Medicine
      • Detmold, Germany, 32756
        • Hospital Lippe-Detmold - Dep. of Anesthesiology and Intensive Care Medicine
      • Dresden, Germany, 01067
        • Krankenhaus Dresden-Friedrichstadt
      • Dresden, Germany, 01307
        • University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med.
      • Erfurt, Germany, 99089
        • HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine
      • Erlangen, Germany, 91054
        • University Erlangen-Nürnberg - Dep. of Medicine IV
      • Freiburg, Germany, 79106
        • University Hospital Freiburg - Dep. of Medicine III
      • Greifswald, Germany, 17475
        • Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine
      • Greifswald, Germany, 17475
        • Ernst-Moritz-Arndt-Universität Greifswald, Dep. of Internal Medicine B
      • Göppingen, Germany, 73035
        • Klinik am Eichert - Dep. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
      • Göttingen, Germany, 37075
        • Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine
      • Halle, Germany, 06097
        • Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology and Intensive Care Medicine
      • Halle, Germany, 06120
        • Hospital Martha-Maria Halle-Dölau gGmbH - Dep. of Anesthesiology and Intensive Care Medicine
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine
      • Hannover, Germany, 30167
        • Klinikum Hannover Nordstadt - Dep. of Anesthesiology and Intensive Care Medicine
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Dep. of Internal Medicine/ Pneumology
      • Heide, Germany, 25746
        • Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg - Dep. of Medicine IV
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg - Dep. of Visceral and Transplantation Surgery
      • Homburg/Saar, Germany, 66421
        • University Hospital Saarland - Deop. of Anesthesiology, Intensive Care Medicine, and Pain Therapy
      • Jena, Germany, 07747
        • University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine
      • Kiel, Germany, 24105
        • University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine
      • Köln, Germany, 50924
        • University Hospital Köln - Dep. of Internal Medicine I
      • Köln, Germany, 51109
        • Hospital Merheim - Dep. of Anesthesiology and Intensive Care Medicine
      • Leipzig, Germany, 04103
        • University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine
      • Ludwigshafen, Germany, 67063
        • Hospital Ludwigshafen am Rhein - Dep. of Cardiac Surgery
      • Luedenscheid, Germany, 58515
        • Klinikum Lüdenscheid - Dep. of Anesthesiology
      • Mannheim, Germany, 68167
        • University Hospital Mannheim - Dep. of Medicine I
      • Munich, Germany, 80336
        • University Hospital Munich - Dep. of Internal Medicine
      • Munich, Germany, 81545
        • Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention
      • Munich, Germany, 81675
        • Klinikum rechts der Isar - Dep. of Anesthesiology
      • Münster, Germany, 48149
        • University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine, Pain Therapy
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann - Dep. of Anesthesiology and Intensive Care Medicine
      • Rostock, Germany, 18057
        • University Hospital Rostock - Dep. of Anesthesiology and Intensive Care Medicine
      • Siegen, Germany, 57074
        • Ev. Jung-Stilling-Krankenhaus - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine
      • Tübingen, Germany, 72076
        • University Hospital Tübingen - Dep. of Medicine
      • Ulm, Germany, 89081
        • University Hospital Ulm - Dep. of Internal Medicine II
      • Würzburg, Germany, 97070
        • Stiftung Juliusspital Würzburg - Dep. of Medicine (Cardiology)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: MeroMono
Monotherapy with meropenem
Drug: 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.
Other Names:
  • Meronem® (meropenem)
Active Comparator: MeroMoxi
Combination therapy with meropenem + moxifloxacin
Drug: 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 Names:
  • Meronem® (meropenem)
  • Avalox® (moxifloxacin)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean total SOFA score
Time Frame: study duration but not longer than 14 days
study duration but not longer than 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mortality
Time Frame: 28 and 90 days
28 and 90 days
ICU and hospital length of stay
Response to therapy
Time Frame: day 7 and day 10
day 7 and day 10
Clinical and microbiological cure
Time Frame: End of study therapy (day 7-14) and release from ICU (max. day 21)
End of study therapy (day 7-14) and release from ICU (max. day 21)
Frequency of adverse events (AEs, SAEs, SUSARs)
Ventilator free days
Time Frame: 28 and 90 days
28 and 90 days
Days without renal replacement therapy
Time Frame: 28 and 90 days
28 and 90 days
Vasopressor free days
Time Frame: 28 and 90 days
28 and 90 days
SOFA-subscores
Antibiotics free days
Time Frame: 28 and 90 days
28 and 90 days
Costs of antibiotic therapy
Time Frame: ICU stay
ICU stay
Frequency of resistances to antibiotics
Time Frame: ICU stay
ICU stay
Frequency of new infections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kompetenznetz Sepsis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Konrad Reinhart, MD, University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine
  • Study Director: Markus Löffler, MD, University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL)
  • Study Director: Thomas Deufel, MD, University Hopitel Jena, Institute for Medical Chemistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EudraCT 2006-006984-21
  • bmbf grant: 01 KI 01 06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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