Description:

ODM derived from http://clinicaltrials.gov/show/NCT00534287

Link:

http://clinicaltrials.gov/show/NCT00534287

Keywords:
Versions (2) ▾
  1. 12/10/13
  2. 4/14/14
Uploaded on:

April 14, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY 4.0
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Eligibility NCT00534287 Severe Sepsis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
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, Gestation
Breast feeding, Nursing
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 within the last 30 days.
Relationship of the patient to study team member (i.e. colleague, relative)