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Severe SepsisPhase 3MaxSepNCT00534287

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

A Phase 3 study testing meropenem and meropenem, moxifloxacin in people with Severe Sepsis and Septic Shock, run by Kompetenznetz Sepsis at 52 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis, Septic Shock
What is being tested?
meropenem and meropenem, moxifloxacin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
52 sitesGermany
Study dates
Oct 2007to Jun 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 22Show fewer
  • 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)

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

Germany52 sites

  • University Hospital Aachen - Dep. of Anesthesiology

    Aachen, 52074

  • Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine

    Augsburg, 86156

  • Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine

    Berlin, 10117

  • Charité Berlin - Dep. of Medicine (Cardiology, Angiology, Pneumology)

    Berlin, 10117

  • Charité Campus Mitte -Dep.of Infectiology and Pneumonology

    Berlin, 10117

  • Charité Campus Benjamin Franklin - Dep. of Medicine IV

    Berlin, 12203

  • Vivantes Klinikum Neukölln - Cardiology

    Berlin, 12313

  • Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy

    Berlin, 12313

  • Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology

    Berlin, 13353

  • Ev. Krankenhaus Gilead I - Dep. of Anesthesiology and Intensive Care Medicine

    Bielefeld, 33617

  • University Hospital Bonn - Dep. of Anesthesiology and Intensive Care Medicine

    Bonn, 53105

  • Städtisches Klinikum Brandenburg - Intensive Care Unit

    Brandenburg, 14770

  • University Hospital Köln - Dep. of Internal Medicine I

    Cologne, 50924

  • Hospital Merheim - Dep. of Anesthesiology and Intensive Care Medicine

    Cologne, 51109

  • Klinikum Darmstadt - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy

    Darmstadt, 64283

  • Klinikum Dessau - Dep. of Medicine

    Dessau, 06847

  • Hospital Lippe-Detmold - Dep. of Anesthesiology and Intensive Care Medicine

    Detmold, 32756

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, 01067

  • University Hospital Dresden - Dep. of Anesthesiology and Intensive Care Med.

    Dresden, 01307

  • HELIOS Klinikum Erfurt - Dep. of Anesthesiology and Intensive Care Medicine

    Erfurt, 99089

  • University Erlangen-Nürnberg - Dep. of Medicine IV

    Erlangen, 91054

  • University Hospital Freiburg - Dep. of Medicine III

    Freiburg im Breisgau, 79106

  • Klinik am Eichert - Dep. of Anesthesiology, Intensive Care Medicine, and Pain Therapy

    Göppingen, 73035

  • Georg August Universität Göttingen - Dep. of Anesthesiology and Intensive Care Medicine

    Göttingen, 37075

  • Ernst-Moritz-Arndt-Universität Greifswald - Dep. of Anesthesiology and Intensive Care Medicine

    Greifswald, 17475

  • Ernst-Moritz-Arndt-Universität Greifswald, Dep. of Internal Medicine B

    Greifswald, 17475

  • Martin-Luther-Universität Halle-Wittenberg - Dep. of Anesthesiology and Intensive Care Medicine

    Halle, 06097

  • Hospital Martha-Maria Halle-Dölau gGmbH - Dep. of Anesthesiology and Intensive Care Medicine

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf - Dep. of Intensive Care Medicine

    Hamburg, 20246

  • Klinikum Hannover Nordstadt - Dep. of Anesthesiology and Intensive Care Medicine

    Hanover, 30167

  • Medizinische Hochschule Hannover, Dep. of Internal Medicine/ Pneumology

    Hanover, 30625

  • Westküstenklinikum Heide - Dep. of Anesthesiology and Intensive Care Medicine

    Heide, 25746

  • University Hospital Heidelberg - Dep. of Medicine IV

    Heidelberg, 69120

  • University Hospital Heidelberg - Dep. of Visceral and Transplantation Surgery

    Heidelberg, 69120

  • University Hospital Saarland - Deop. of Anesthesiology, Intensive Care Medicine, and Pain Therapy

    Homburg/Saar, 66421

  • University Hospital Jena, Dep. of Anesthesiology and Intensive Care Medicine

    Jena, 07747

  • University Hospital Kiel - Dep. of. Anesthesiology and Intensive Care Medicine

    Kiel, 24105

  • University Hospital Leipzig - Dep. of Anesthesiology and Intensive Care Medicine

    Leipzig, 04103

  • Klinikum Lüdenscheid - Dep. of Anesthesiology

    Lüdenscheid, 58515

  • Hospital Ludwigshafen am Rhein - Dep. of Cardiac Surgery

    Ludwigshafen, 67063

  • University Hospital Mannheim - Dep. of Medicine I

    Mannheim, 68167

  • University Hospital Munich - Dep. of Internal Medicine

    Munich, 80336

  • Hospital Munich Harlaching - Dep. of Internal Acute Medicine and Prevention

    Munich, 81545

  • Klinikum rechts der Isar - Dep. of Anesthesiology

    Munich, 81675

  • University Hospital Münster - Dep. of Anesthesiology and Intensive Care Medicine

    Münster, 48149

  • Klinikum Oldenburg - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine, Pain Therapy

    Oldenburg, 26133

  • Klinikum Ernst von Bergmann - Dep. of Anesthesiology and Intensive Care Medicine

    Potsdam, 14467

  • University Hospital Rostock - Dep. of Anesthesiology and Intensive Care Medicine

    Rostock, 18057

  • Ev. Jung-Stilling-Krankenhaus - Dep. of Anesthesiology, Intensive Care Medicine, Emergency Medicine

    Siegen, 57074

  • University Hospital Tübingen - Dep. of Medicine

    Tübingen, 72076

  • University Hospital Ulm - Dep. of Internal Medicine II

    Ulm, 89081

  • Stiftung Juliusspital Würzburg - Dep. of Medicine (Cardiology)

    Würzburg, 97070

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
meropenem, meropenem, moxifloxacin
Keywords
sepsis, antibiotics, carbapenems, fluoroquinolones, Severe sepsis and septic shock
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • meropenemDrug

    Also called Meronem® (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, moxifloxacinDrug

    Also called Meronem® (meropenem), Avalox® (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.

Study groups in NCT00534287
Study groupRoleWhat they receive
MeroMonoActive comparatorMonotherapy with meropenem
Receives: Drug: meropenem
MeroMoxiActive comparatorCombination therapy with meropenem + moxifloxacin
Receives: Drug: meropenem, moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean total SOFA score

    Measured: study duration but not longer than 14 days

Secondary outcomes (13)

  1. Mortality

    Measured: 28 and 90 days

  2. ICU and hospital length of stay

  3. Response to therapy

    Measured: day 7 and day 10

  4. Clinical and microbiological cure

    Measured: End of study therapy (day 7-14) and release from ICU (max. day 21)

  5. Frequency of adverse events (AEs, SAEs, SUSARs)

  6. Ventilator free days

    Measured: 28 and 90 days

  7. Days without renal replacement therapy

    Measured: 28 and 90 days

  8. Vasopressor free days

    Measured: 28 and 90 days

  9. SOFA-subscores

  10. Antibiotics free days

    Measured: 28 and 90 days

  11. Costs of antibiotic therapy

    Measured: ICU stay

  12. Frequency of resistances to antibiotics

    Measured: ICU stay

  13. Frequency of new infections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionApr 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00534287
Sponsor's protocol ID
EudraCT 2006-006984-21
Other IDs
bmbf grant: 01 KI 01 06
Acronym
MaxSep
Status last verified
Jun 2012
First submitted
21 Sep 2007
Last updated
29 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 1597042

  • 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.

    PubMed 17051663

  • 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.

    PubMed 15542958

  • 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.

    PubMed 14599631

  • 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.

    PubMed 15288826

  • 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.

    PubMed 17323051

  • 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.

    PubMed 20336279

  • 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.

    PubMed 22692171

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing meropenem and meropenem, moxifloxacin in people with Severe Sepsis and Septic Shock, run by Kompetenznetz Sepsis at 52 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean total SOFA score (time frame: study duration but not longer than 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00534287, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.

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