EUCTR2006-006984-21-DE
Active, not recruiting
Not Applicable
prospective, randomized, open, multicentre trial to assess the influence of empiric antibiotic monotherapy with meropenem (Meronem) versus combination with moxifloxacin (Avalox) on the organ function of patients with severe sepsis and septic shock
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- severe sepsis / septic shock
- Sponsor
- Friedrich-Schiller-University of Jena
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Presence of severe sepsis or septic shock according to the definitions of the SepNet
- •\- Beginning of severe sepsis or of septic shock within the last 24 hours
- •\- written informed consent of the patient or his court\-appointed guardian
- •\- women of child bearing potential using contraception with a failure rate of less than 1% per year
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Age \< 18 years
- •\- pregnancy (women of child bearing potential with positive pregnancy test)
- •\- nursing women
- •\- prior treatment with meropenem, imipenem or ertapenem within the last four weeks (\> one daily dose)
- •\- prior treatment with moxifloxacin, ciprofloxacin or levofloxacin within the last four weeks (\> one daily dose)
- •\- prior treatment with pseudomonas\-specific cephalosporins (f.e. cefepime, ceftazidim, cefpirom) or piperacillin within the last 48 hours (\> one daily dose)
- •\- presence of infection where guidelines recommend an antimicrobiological therapy other than the study drug (f.e. active endocarditis)
- •\- proven or urgent clinical suspicion of a pathogen where study drug is not effective (f.e. active tuberculosis, infection with MRSA or VRE)
- •\- known allergy to the trial medication
- •\- diseases or impairments affecting the tendons after a previous therapy with chinolon\-derivatives
Outcomes
Primary Outcomes
Not specified
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