Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01306825
Verified March 2015 by University Hospital, Strasbourg, France. Recruitment status was: Recruiting
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.
Patients' percentage of which the intra-osseous daptomycin concentration is ≥ 8 times MIC (if available) or ≥ 8 times critical concentration (if Bacteriological documentation is unavailable) [ Time Frame: 5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient under treatment with daptomycin and undergoing imperative surgery with bone withdrawal
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