severe sepsis / septic shock MedDRA version: 9.1 Level: LLT Classification code 10040047 Term: Sepsis
Conditions
Interventions
Trade Name: Meronem 1000 mg
Product Name: Meronem
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: MEROPENEM
CAS Number: 96036032
Concentration unit: mg milligram(s)
Concentr
Sponsors
Friedrich-Schiller-University of Jena
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: - Age 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed