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
- Conditions
- severe sepsis / septic shockMedDRA version: 9.1Level: LLTClassification code 10040047Term: Sepsis
- Registration Number
- EUCTR2006-006984-21-DE
- Lead Sponsor
- Friedrich-Schiller-University of Jena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
- documented congenital or acquired elongation of the QT-interval
- simultaneous application of other medications resulting in elongated QT-intervals should be avoided
- electrolyte imbalance, particularly patients with uncorrected hypokalemia
- clinically significant bradycardia
- clinically significant heart insufficiency with reduced left-ventricular ejection fraction
- symptomatic arrhythmia in anamnesis
- decreased liver function (Child Pugh C) and / or transaminase level more than fivefold the normal value
- therapy restriction (e. g. DNR-order)
- bad prognosis due to accompanying disease(s)
- concurrent or previous (within the last 30 days) participation in other clinical trials
- close relationship to the trial physician (co-workers, relatives, colleagues)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: effect of antibiotic therapy on morbidity;Secondary Objective: mortality, hospital and ICU length of stay, clinical & microbiological cure of infection, recurrence of infections, organ dysfunction, duration of mechanical ventilation, safety of the IMPs;Primary end point(s): Average total SOFA-score until the end of trial. However, the maximum duration for scoring is 14 days.
- Secondary Outcome Measures
Name Time Method