NCT03209934|Completed
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Sponsor study identifier
observational
43
0 countries
N/A
Study Start
July 2014
Actual (reported)Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Actual (reported)January 2015
Actual (reported)January 2015
Actual (reported)July 4, 2017
Actual (reported)July 6, 2017
Actual (reported)Measure of daptomycin through plasma concentration (Cmin)
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
300 days
patients who received daptomycin \>6 mg/kg/d as an alternative therapy for complex BJI from January 2011 to July 2013 in a French regional reference center.
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43 participants (actual enrollment reported by the registry).
First Submitted
July 4, 2017
First Posted
July 6, 2017
Study Start
July 2014
Actual (reported)Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
July 6, 2017
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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