Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-05 @ 1:05 AM
Study NCT ID:
NCT03209934
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daptomycin > 6 mg/kg/Day as Salvage Therapy in Patients With Complex Bone and Joint Infection: Cohort Study in a Regionalreference Center
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Daptomycin > 6 mg/kg/Day as Salvage Therapy in Patients With Complex Bone and Joint Infection: Cohort Study in a Regionalreference Center
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: