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

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ClinicalTrials.gov Identifier: NCT00534287
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : June 29, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: meropenem Drug: meropenem, moxifloxacin Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2007
Primary Completion Date : April 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: 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)


Outcome Measures

Primary Outcome Measures :
  1. Mean total SOFA score [ Time Frame: study duration but not longer than 14 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 and 90 days ]
  2. ICU and hospital length of stay
  3. Response to therapy [ Time Frame: day 7 and day 10 ]
  4. Clinical and microbiological cure [ Time Frame: 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 [ Time Frame: 28 and 90 days ]
  7. Days without renal replacement therapy [ Time Frame: 28 and 90 days ]
  8. Vasopressor free days [ Time Frame: 28 and 90 days ]
  9. SOFA-subscores
  10. Antibiotics free days [ Time Frame: 28 and 90 days ]
  11. Costs of antibiotic therapy [ Time Frame: ICU stay ]
  12. Frequency of resistances to antibiotics [ Time Frame: ICU stay ]
  13. Frequency of new infections

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534287


  Show 52 Study Locations
Sponsors and Collaborators
Kompetenznetz Sepsis
AstraZeneca
Bayer
Investigators
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
More Information

Additional Information:
Publications:

Responsible Party: Kompetenznetz Sepsis
ClinicalTrials.gov Identifier: NCT00534287     History of Changes
Other Study ID Numbers: EudraCT 2006-006984-21
bmbf grant: 01 KI 01 06
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012

Keywords provided by Kompetenznetz Sepsis:
sepsis
antibiotics
carbapenems
fluoroquinolones
Severe sepsis and septic shock

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Moxifloxacin
Fluoroquinolones
Meropenem
Thienamycins
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors