Comparison of the concentrations of the antibiotic compound Daptomycin in serum, cartilage-, muscle and subcutaneous tissue after a preoperative intravenous administration (Klinische Studie zum Vergleich von Serum – und Gewebekonzentrationen in Subkutis, Muskel, Knorpel und Knochen des Antibiotikums Daptomycin nach präoperativer, intravenöser Applikation zur Infektionsprophylaxe bei orthopädischen Eingriffen) - Daptomycin-Concentration study

niversity Medical Center Freiburg0 个研究点目标入组 18 人开始时间: 2007年12月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Only patients which are planed for elektive surgery and who would in any case receive an antibiotic prophylaxis as a standard procedure
•- age 18 y and older
•-- Legally competent
•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

•-- Legally incompetent
•- Parallel participation in another interventional study which could interfere with this clinical trial and/or participation in another clinical study within the last 4 weeks
•- Infection prior to the surgery
•- Current treatment with antibiotics
•- Known or current abuse of drugs or alcohol
•- Person who is in a dependent relationship with the physician or may consent under duress
•-Patients with a total body weight of less than 55 kg
•Contraindications according to the SmPC:
•- Impaired renal function
•- Impaired liver function
•- Drugs with expected interference to the IMP (according to SmPC)
•- Current or planned pregnancy; lactating patients
•- Women who do not use one of the following contraceptive methods:
•- condoms for women, diaphragm or loop each in combination with spermicids or
•- intrauterine device or
•- hormonal contraception in combination with a mechanic contraceptive method

发起方

niversity Medical Center Freiburg