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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kompetenznetz Sepsis
• Collaborators: AstraZeneca; Bayer
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Fluoroquinolones; Meropenem; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Thienamycins

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)