Effects of Oritavancin on Coagulation Tests in the Clinical Laboratory Article

Industry Collaboration International Collaboration

cited authors

  • Belley, Adam, Robson, Richard, Francis, John L., Adcock, Dorothy M., Tiefenbacher, Stefan, Rubino, Christopher M., Moeck, Greg, Sylvester, David, Dudley, Michael N., Loutit, Jeffery

funding text

  • This study was funded by The Medicines Company, Parsippany, NJ. Employees of The Medicines Company had a role as authors in the study design, interpretation, and the decision to submit the work for publication. Medical writing assistance was funded by The Medicines Company, Parsippany, NJ, under the direction of the authors by Latoya M. Mitchell of PharmaWrite, LLC, Princeton, NJ. A.B. is an employee of The Medicines Company; R.R.'s institution received clinical research funding from The Medicines Company; J.L.F. is a consultant for The Medicines Company; D.M.A.'s institution received research funding from The Medicines Company; S.T.'s institution received research funding from The Medicines Company; C.M.R. is a consultant for The Medicines Company; G.M. is an employee of The Medicines Company; D.S. is an employee of The Medicines Company; M.N.D. is an employee of The Medicines Company; J.L. is an employee of The Medicines Company.

abstract

  • Previous studies have shown that some lipoglycopeptide and lipopep-tide antimicrobial agents may cause falsely elevated values for some phospholipid-dependent coagulation tests. The effect of oritavancin, a lipoglycopeptide antibiotic, on coagulation test results was explored using pooled human plasma samples spiked with drug and in a clinical study after an infusion of a single 1,200-mg intravenous dose of oritavancin in normal healthy volunteers. Pooled plasma with oritavancin added ex vivo showed concentration-dependent prolongation of prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (aPTT), and dilute Russell viper venom time (DRVVT) test results. In contrast, oritavancin had no effect on the activated protein C resistance assay, chromogenic antifactor Xa assay (anti-FXa), thrombin time, and an immunoassay for the laboratory diagnosis of heparin-induced thrombocytopenia. In participants that received a single dose of oritavancin, elevations in PT/INR result, aPTT, DRVVT, activated clotting time, and silica clotting time occurred, with the maximum times to resolution of test interference determined to be 12, 120, 72, 24, and 18 h, respectively. The anti-FXa assay was unaffected, whereas transient elevations in D dimer levels were observed in 30% of participants, with a maximum time to resolution of 72 h. Although oritavancin has no impact on the coagulation system in vivo, a single dose of oritavancin can produce falsely elevated values of some coagulation tests used to monitor hemostasis. The interference of oritavancin on affected tests is transient, and the test results revert to normal ranges within specified times after dosing.

Publication Date

  • February 1, 2017

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published in

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volume

  • 61

issue

  • 2

WoS Citations

  • 0

WoS References

  • 13