Clinical Trials Directory

Trials / Completed

CompletedNCT03209934

Daptomycin > 6 mg/kg/Day as Salvage Therapy in Patients With Complex Bone and Joint Infection: Cohort Study in a Regionalreference Center

Status
Completed
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

The choice of antimicrobial therapy to treat complex bone and joint infections (BJI) is challenging, requiring consideration of: (i) the problem of bone diffusion; (ii) the necessity of using antimicrobials active against bacterial biofilms; (iii) the growing incidence of antibiotic resistance; and (iv) the high risk of severe adverse events (SAE) in response to first-line antimicrobials in these patients. Consequently, off-label use of recently developed antimicrobials, such as daptomycin, is frequently required as salvage therapy in complex BJI. Even if daptomycin does not have approval for the treatment of BJI, the Infectious Diseases Society of America guidelines propose this antibiotic as alternative therapy for prosthetic joint infection. The recommended dose is 6 mg/kg/d, whereas recent data support the use of higher doses in these patients as bone penetration of daptomycin is limited. The present cohort study aimed to assess the safety and efficacy of prolonged high-dose (\>6 mg/kg/d) daptomycin salvage therapy in patients with complex BJI.

Conditions

Timeline

Start date
2014-07-01
Primary completion
2015-01-01
Completion
2015-01-01
First posted
2017-07-06
Last updated
2017-07-06

Source: ClinicalTrials.gov record NCT03209934. Inclusion in this directory is not an endorsement.