Impact of telavancin on prothrombin time and activated partial thromboplastin time as determined using point-of-care coagulometers

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• 作者：Michael P. Ero (1)
  Nathaniel R. Harvey (1)
  Jack L. Harbert (1)
  James W. Janc (2)
  Kay H. Chin (2)
  Steven L. Barriere (2)
  
• 关键词：PT/INR ; Point ; of ; care ; Telavancin ; Prothrombin time ; Activated partial thromboplastin time
• 刊名：Journal of Thrombosis and Thrombolysis
• 出版年：2014
• 出版时间：August 2014
• 年：2014
• 卷：38
• 期：2
• 页码：235-240
• 全文大小：512 KB
• 参考文献：1. Shaw JP, Seroogy J, Kaniga K, Higgins DL, Kitt M, Barriere S (2005) Pharmacokinetics, serum inhibitory and bactericidal activity, and safety of telavancin in healthy subjects. Antimicrob Agents Chemother 49:195-01. doi:10.1128/AAC.49.1.195-201.2005 CrossRef
  2. Stryjewski ME, O’Riordan WD, Lau WK, Pien FD, Dunbar LM, Vallee M, Fowler VG Jr, Chu VH, Spencer E, Barriere SL, Kitt MM, Cabell CH, Corey GR (2005) Telavancin versus standard therapy for treatment of complicated skin and soft-tissue infections due to Gram-positive bacteria. Clin Infect Dis 40:1601-607. doi:10.1086/429914 CrossRef
  3. Stryjewski ME, Chu VH, O’Riordan WD, Warren BL, Dunbar LM, Young DM, Vallee M, Fowler VG Jr, Morganroth J, Barriere SL, Kitt MM, Corey GR (2006) Telavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study. Antimicrob Agents Chemother 50:862-67. doi:10.1128/AAC.50.3.862-867.2006 CrossRef
  4. Stryjewski ME, Graham DR, Wilson SE, O’Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR (2008) Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by Gram-positive organisms. Clin Infect Dis 46:1683-693. doi:10.1086/587896 CrossRef
  5. Barriere SL, Goldberg MR, Janc JW, Higgins DL, Macy PA, Adcock DM (2011) Effects of telavancin on coagulation test results. Int J Clin Pract 65:784-89. doi:10.1111/j.1742-1241.2011.02668.x CrossRef
  6. U.S. Food and Drug Administration (2009) Clinical Laboratory Improvement Amendments (CLIA). http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124105.htm. Accessed 24 April 2013
  7. Gosselin R, Dager W, Roberts A, Freeman L, Gandy L, Gregg J, Dwyre D (2011) Effect of telavancin (Vibativ) on routine coagulation test results. Am J Clin Pathol 136:848-54. doi:10.1309/AJCPDPL4G7CERYJU CrossRef
  8. Amanatullah DF, Lopez MJ, Gosselin RC, Gupta MC (2013) Case report: artificial elevation of prothrombin time by telavancin. Clin Orthop Relat Res 471:332-35. doi:10.1007/s11999-012-2612-0 CrossRef
  9. Webster PS, Oleson FB Jr, Paterson DL, Arkin CF, Mangili A, Craven DE, Adcock DM, Lindfield KC, Knapp AG, Martone WJ (2008) Interaction of daptomycin with two recombinant thromboplastin reagents leads to falsely prolonged patient prothrombin time/International Normalized Ratio results. Blood Coagul Fibrinolysis 19:32-8. doi:10.1097/MBC.0b013e3282f10275 CrossRef
  
• 作者单位：Michael P. Ero (1)
  Nathaniel R. Harvey (1)
  Jack L. Harbert (1)
  James W. Janc (2)
  Kay H. Chin (2)
  Steven L. Barriere (2)
  
  1. Specialized Coagulation Laboratory, Machaon Diagnostics, Inc., Sherrick Research Building, 3023 Summit Street, Oakland, CA, 94609, USA
  2. Theravance, Inc., South San Francisco, CA, USA
  
• ISSN：1573-742X

文摘

Telavancin is approved in the United States, Canada, and Europe (At the time of submission, the telavancin European marketing authorization for nosocomial pneumonia was suspended until Theravance provides evidence of a new European Medicines Agency approved supplier) as an antibiotic to treat certain Gram-positive bacterial skin infections. Telavancin has been shown to prolong plasmatic prothrombin (PT) and activated partial thromboplastin (aPTT) clotting times in clinical diagnostic lab-based assays. In this study, we evaluated the potential for telavancin to prolong whole blood PT/International Normalized Ratio (INR) and aPTT tests on point-of-care (POC) instruments. Whole blood collected from 8 healthy subjects was supplemented with telavancin to final concentrations of 0, 10, 20, and 100?μg/ml. Final concentrations were selected to match trough, twice trough, and peak plasma levels following the approved 10?mg/kg dose. Four widely employed POC coagulation instruments were chosen to be representative of the POC platforms currently in use.. These systems were the Roche Coaguchek XS, the Abbott iSTAT, the ITC Hemochron SIG+, and the Alere INRatio2 POC devices. The PT/INR measured by the Coaguchek XS showed the greatest sensitivity to the presence of telavancin. The PT/INR measured by the Hemochron SIG+ and iSTAT were sensitive to telavancin but to a lesser extent. The INRatio2 was the least sensitive to the presence of telavancin when testing the whole blood PT/INR. Only the Hemochron SIG+ device was capable of measuring aPTT and showed a concentration-dependent increase in aPTT. This study supports the current recommendation that PT and aPTT monitoring be conducted immediately to the next dose of telavancin when coagulation parameters are tested using POC instrumentation.