Patients, who are treated with Moxifloxacin due to clinical indication of respiratory infection or soft tissue infection
Conditions
Sponsors
University Hospital Tubeingen, Department for Anaesthesiology and Intensive Care Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -age of at least 18 years - normal gastrointestinal motility (i.e. reflux via gastric tube =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pregnancy or breast feeding - age above 75 years -compromised liver function, i.e. serum levels of bilirubine higher than the twofold of the upper standard value or alanin-aminotransferase or aspartat-aminotransferase higher than the threefold of the upper standard value or liver cirrhosis -compromised renal function, i.e. creatinin-clearance 300 ml/die via the gastric tube or vomiting -participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to compare maximum serum levels of moxifloxacin reached by intravenous application versus enteral application. ;Secondary Objective: to compare the area under the concentration curve received by intravenous application versus enteral application.;Primary end point(s): The primary endpoint of the study is the comparison of the maximum serum levels of moxifloxacin after intravenous versus enteral application of 400 mg of moxifloxacin in the steady state level. ;Timepoint(s) of evaluation of this end point: The primary endpoint of the study is evaluated with the last blood sample on day 8 after inclusion (24 hours after the last oral intake of Moxifloxacin). After completion of the pharmakokinetic examination patients are monitored regarding any adverse event during their whole intensive care sta | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): area under the concentration curve of moxifloxacin serum levels after intravenous versus enteral application of 400 mg moxifloxacin ;Timepoint(s) of evaluation of this end point: The evaluation can be done when the last of blood samples is taken; for practical reasons the blood samples will be processed, frozen and then be analyzed in batches of samples taken from 3 or 4 patients. | — |
Countries
Germany
Outcome results
None listed