Pharmacokinetica of levofloxacine in bone

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003898-42-DE

Enrollment

Registered

2007-10-10

Start date

2008-03-19

Completion date

Unknown

Last updated

2012-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hip or knee replacement

Interventions

Trade Name: Tavanic Pharmaceutical Form: INN or Proposed INN: levofloxacine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: bone and plasma concentration of antibiotics;Secondary Objective: does not apply;Primary end point(s): The potential benefit of the study cloud be the identification of criteria for the development of new antibiotics that would be ebtter than the currently used for the pophylaxes of bone infection in patients. The aim of the current application is a correlation between the time of application, the dosing and the plasma levels of levofloxacine in relation to its concentrations in sub regions of the hip or knee. It is routine to apply levofloxacine before hip or knee replacement surgery ist started.	—

Measure

Time frame

Main Objective: bone and plasma concentration of antibiotics;Secondary Objective: does not apply;Primary end point(s): The potential benefit of the study cloud be the identification of criteria for the development of new antibiotics that would be ebtter than the currently used for the pophylaxes of bone infection in patients. The aim of the current application is a correlation between the time of application, the dosing and the plasma levels of levofloxacine in relation to its concentrations in sub regions of the hip or knee. It is routine to apply levofloxacine before hip or knee replacement surgery ist started.

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026