Clinical trial NCT01306825: Clinical Evaluation of Daptomycin Bone Penetration
Official title: Clinical Evaluation of Daptomycin Bone Penetration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone and Joint Infections
Keywords: Daptomycin
Bone disease,infectious
Osteomyelitis
Diabetic foot
Staphylococcus aureus
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient under treatment with daptomycin and undergoing imperative surgery with bone withdrawal

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin
Secondary outcomes:
Other outcomes:
Locations:
city: Illkirch-Graffenstaden
country: France
facility: Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann -
city: Strasbourg
country: France
facility: Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé
city: Strasbourg
country: France
facility: Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
name: Nicolas Lefebvre, MD
role: STUDY_DIRECTOR
References: