Serumspiegel von intravenös und enteral appliziertem Moxifloxacin bei kritisch kranken Intensivpatiente

Conditions: Patients, who are treated with Moxifloxacin due to clinical indication of respiratory infection or soft tissue infection
Therapeutic area: Body processes [G] - Microbiological Phenomena [G06]

Registration Number: EUCTR2007-004941-13-DE

Lead Sponsor: niversity Hospital Tubeingen, Department for Anaesthesiology and Intensive Care Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

-age of at least 18 years
- normal gastrointestinal motility (i.e. reflux via gastric tube < 300 ml/d, no vomiting, defecation within the first three days after ICU admission)
-treatment of a respiratory tract or soft tissue infection with Moxifloxacin;
-sequential application planned, i.e. switch from intravenous to enteral application after four days
-written informed consent of the patient or her/his legal representative

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

- 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 < 30 ml/min.
-oral co-medication with mineralic antacids, sucralfate,magnesium, iron additives, calcium or vitamins
-postpyloric enteral nutrition
-known intestinal disease, e.g. Crohn´s disease
-symptoms of irregular intestinal motility,i.e.:
diarrhea (defecation more than 3x a day)
reflux of enteral secretions > 300 ml/die via the gastric tube or vomiting
-participation in another clinical study