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Clinical Evaluation of Daptomycin Bone Penetration

This study is currently Recruiting

March 2011 By University Hospital, Strasbourg, France

First Recieved on February 25, 2011

Last Updated on August 24, 2011

Sponsor: University Hospital, Strasbourg, France
Collaborators:
Information provided by: University Hospital, Strasbourg, France
Identifier: NCT01306825

Purpose

Bone and joint infections are commonly due to Gram-positive bacteria. Treatment of these infections is difficult because of the need of prolonged duration of antimicrobial agents in combination with surgical procedure. Moreover, in recent years, a growing resistance pattern to various antimicrobial agents has been observed for Gram-positive bacteria. Consequently, there is an urgent need for new drugs with high bone penetration for the treatment of those infections. The investigators hypothesized that daptomycin allow to achieve high concentrations in bone compartments.

Study Type: Observational
Study Design: Observational Model: Case-Only, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion criteria: - Patient under treatment with daptomycin for more than 3 days with dosage at 6 mg/kg - Patient undergoing imperative surgery with bone withdrawal - Signed, and dated informed consent as defined by the Institutional Review Board - Male and female patients older than 18 years of age - Patients with social insurance - Patient with information on previous mandatory medical examination Exclusion criteria : - Patient with no treatment by daptomycin or with a dosage < 6mg/kg or with less than 3 doses of daptomycine - Patient with no need for surgery - Patient younger than 18 years of age - Pregnant and nursing women - Patient refusal for inclusion - Patients with deprived liberty - Inability to complete the informed consent process because of problems with mental capacity

Investigators

  • Investigator: Nicolas Lefebvre, MD - Study Director - Service des maladies infectieuses et tropicales - Nouvel H?pital Civil - H?pitaux Universitaires de Strasbourg

Locations

  • Service d'Orthop?die - H?pital Centre de Chirurgie Orthop?die et de la Main (CCOM) - H?pitaux Universitaires de Strasbourg - 10 av Achille Baumann -

    Illkirch-Graffenstaden, 67400 France

  • Service des maladies infectieuses et tropicales - Nouvel H?pital Civil - H?pitaux Universitaires de Strasbourg

    Strasbourg, 67091 France

  • Plateau Technique de Microbiologie - H?pitaux Universitaires de Strasbourg - 1, rue Koeberl?

    Strasbourg, 67000 France

Conditions related to this trial:

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