Pharmacokinetica of levofloxacine in bone

• Conditions: hip or knee replacement

• Registration Number: EUCTR2007-003898-42-DE
• Lead Sponsor: Institut for Pharmacology and Toxicology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-10
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

We will include patients (women and Men) from 40 to 65 years which are, für clinical reasons, undergoing a hip or knee replacement therapy in the participating entre. The patients must be able to understand and sign informed consent that the patients is willing to participate in the study.

Women must not be pregnant.
We will use only patients with no relevant and accompanying dieseases like:
prior traumatic surgery
past or present osteomyelitis
impaired function of the heart (>NYHA II)
impaired function of the kidney (creatinine > 1,5mg/dl)
impaired function of the liver (high GOT-value)
high body mass index (BMI > 35)
allergy against gyrase inhibitors
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who are unable to consent will not be included in the study.

We will exclude patients with relevant and accompanying dieseases like:

prior traumatic surgery
past or present osteomyelitis
impaired function of the heart (>NYHA II)
impaired function of the kidney (creatinine > 1,5mg/dl)
impaired function of the liver (high GOT-value)
high body mass index (BMI > 35)
allergy against gyrase inhibitors
epilepsy
anemia
leucocytopenia
thrombocytopenia

Study & Design

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