Clinical Evaluation of Daptomycin Bone Penetration

Bone and Joint Infections Clinical Trial

— DAPTO-HUS  

Official title:

Clinical Evaluation of Daptomycin Bone Penetration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01306825
• Other study ID #: 4683
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2011
• Last updated: June 17, 2015
• Start date: May 2011
• Est. completion date: November 2015

Study information

• Verified date: March 2015
• Source: University Hospital, Strasbourg, France
• Contact: Nicolas Lefebvre, MD
• Phone: 33 3 69 55 05 45
• Email: nicolas.lefebvre[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone and Joint Infections

Locations

Country	Name	City	State
France	Service d'Orthopédie - Hôpital Centre de Chirurgie Orthopédie et de la Main (CCOM) - Hôpitaux Universitaires de Strasbourg - 10 av Achille Baumann -	Illkirch-Graffenstaden
France	Plateau Technique de Microbiologie - Hôpitaux Universitaires de Strasbourg - 1, rue Koeberlé	Strasbourg
France	Service des maladies infectieuses et tropicales - Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		5 min before started administration of daptomycin, 5 min after administration of daptomycin and at random after perfusion of daptomycin	No