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

• Conditions: Elective orthopedic surgery; MedDRA version: 9.1Level: PTClassification code 10042609Term: Surgery

• Registration Number: EUCTR2007-004990-24-DE
• Lead Sponsor: niversity Medical Center Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

- 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

Exclusion Criteria

-- 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)

Women:
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of the concentrations of Daptomycin in serum and tissue (cartilage, subcutaneous tissue, muscle) at different time intervals between 1 to 4 hours after the intravenous preoperative administration<br><br>;Secondary Objective: Effectiveness and tolerability (safety) of the prevention of infections by surveillance and documentation of the postoperative clinical course ;Primary end point(s): The concentrations of Daptomycin post surgery in serum and tissue determined by HPLC analysis, then plotted and evaluated in a descriptive manner.