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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03209934

Enrollment

Registered

2017-07-06

Start date

2014-07-31

Completion date

2015-01-31

Last updated

2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone and Joint Infection, Treated by Daptomycin

Keywords

Bone and Joint Infection, Daptomycin, Eosinophilic pneumonia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* patients having BJI treated by daptomycin at \>6 mg/kg/d

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Measure of daptomycin through plasma concentration (Cmin)	300 days	The approximal maximal treatment duration is 300 days. Daptomycin trough plasma concentration (Cmin) is determined monthly to detect any patients with daptomycin trough levels (Cmin) over 24 mg/L. Cmin is determined 24 h after daptomycin injection (just before reinjection, if performed) using a validated HPLC process developed in the laboratory and a diode array UV detector. Cmin \> 24 mg/L was considered an overdose, as the risk of high CPK levels (with or without symptoms of myopathy) is greater above this threshold

Outcome results