To evaluate feasibility of Moxifloxacin determination in septic patients
Conditions
Interventions
Trade Name: AVELOX 400 mg/250 ml - Infusionsloesung
Product Name: AVELOX 400 mg/250 ml - Infusionsloesung
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: MOXIFLOXACIN HYDROCHLORIDE
CAS
Sponsors
Medizinische Universität Wien, Univ.Klinik f.klinische Pharmakologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Indication to Moxifloxacin therapy • No Moxifloxacin therapy within the last 12 hours. Severe sepsis or septic shock as diagnosed according to the criteria of ACCP/SCCM and the MAXSEP Study within 24 hours: a) Severe sepsis • Presence of microbiologically proven, clinically proven, or suspected infection • Presence of Systemic Inflammatory Response Syndrome (SIRS) (fulfillment of at least two of the following criteria): - hypo- (=36°C) or hyperthermia (=38°C) - tachycardia (=90 bpm) - tachypnea (=20 breaths/min) and/or an arterial pCO2 =4.3 kPa (32 mmHg) and/or mechanical ventilation - leukocytosis =12,000/µl or leukopenia = 4,000/µl and/or a left shift in the differential white blood cell count =10 percent. • Development of at least one organ dysfunction within the last 24 hours (one of the following criteria had to be fulfilled): - presence of acute encephalopathia with reduced vigilance, agitation, disorientation, delirium not explained by psychotropic medication - thrombocytopenia = 100.000/µl or a drop in the thrombocyte count >30 percent within 24 hours not explained by hemorrhage - arterial hypoxemia with an arterial pO2 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Allergy against study drug. • Bleeding disorders which prohibit intramuscular implantation of the microdialysis probe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1) To evaluate the previously described TTPS score 2) To measure concentrations of Moxifloxacin in the interstitial space fluid of subcutaneous adipose tissue- and skeletal muscle and to relate these concentrations to corresponding plasma concentrations. 3) To determine kill rates of selected bacterial strains in vitro exposed to the time versus concentration profiles of Moxifloxacin determined in vivo. ;Primary end point(s): Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2) in the microdialysate and plasma after single dose and at steady state.;Main Objective: Pilot phase: To evaluate feasibility of Moxifloxacin determination in septic patients in a multicenter setting and to explore pharmacokinetic variability to determine sample size for the main phase. Main phase: To prospectively identify factors influencing tissue penetration of antimicrobials in patients with sepsis . | — |
Countries
Austria
Outcome results
None listed