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.