Informations générales (source: ClinicalTrials.gov)
Clinical Evaluation of Daptomycin Bone Penetration (DAPTO-HUS)
Observational
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
mai 2011
novembre 2015
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé - 67000 - Strasbourg - France | JEHL François, PHARM D | Contact (sur clinicalTrials) | |||
| Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg - 67091 - Strasbourg - France | Nicolas Lefebvre, MD | Contact (sur clinicalTrials) | |||
| Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann - - 67400 - Illkirch-Graffenstaden - France | Jeannot GAUDIAS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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