A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: The ASSURE study

BMC Infectious Diseases

Volumn 14, Issue 1, 2014, Pages

  Stryjewski, Martin E ^a   Lentnek, Arnold ^b   O'Riordan, William ^c   Pullman, John ^d   Tambyah, Paul A ^e   Miró, Jose M ^f   Fowler, Vance G ^g,h   Barriere, Steven L ⁱ   Kitt, Michael M ⁱ   Corey, G R ^g,h  

^a CEMIC   (Argentina)

^b Wellstar Infectious Disease   (United States)

^c ECMC Department of Surgery   (United States)

^d Mercury Street Medical Group   (United States)

^e NATIONAL UNIVERSITY HEALTH SYSTEM   (Singapore)

^f UNIVERSITY OF BARCELONA   (Spain)

^g DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^h DUKE UNIVERSITY MEDICAL CENTER   (United States)

ⁱ THERAVANCE INC   (United States)

Author keywords

Bacteremia; Staphylococcus aureus; Telavancin; Vancomycin

Indexed keywords

CLOXACILLIN; CREATININE; NAFCILLIN; OXACILLIN; TELAVANCIN; UREA; VANCOMYCIN; AMINOGLYCOSIDE; ANTIINFECTIVE AGENT; PENICILLIN DERIVATIVE;

ACUTE KIDNEY FAILURE; ADULT; AGITATION; ANEMIA; ARTICLE; ATELECTASIS; BEHAVIOR DISORDER; CATHETER INFECTION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DEEP VEIN THROMBOSIS; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPNEA; EOSINOPHILIA; ERYTHEMA; FEMALE; FEVER; HEADACHE; HEMATURIA; HUMAN; HYPOKALEMIA; INSOMNIA; MAJOR CLINICAL STUDY; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION; MULTICENTER STUDY; NAUSEA; PHASE 2 CLINICAL TRIAL; PHLEBITIS; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; STAPHYLOCOCCAL BACTEREMIA; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; UREA BLOOD LEVEL; URINARY TRACT INFECTION; VOMITING; AGED; BACTEREMIA; CLINICAL TRIAL; COMPLICATION; DRUG EFFECTS; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; MICROBIOLOGY; MIDDLE AGED; PATHOGENICITY; STAPHYLOCOCCAL INFECTIONS; STAPHYLOCOCCUS AUREUS; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; AMINOGLYCOSIDES; ANTI-BACTERIAL AGENTS; BACTEREMIA; CATHETER-RELATED INFECTIONS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; MIDDLE AGED; PENICILLINS; STAPHYLOCOCCAL INFECTIONS; STAPHYLOCOCCUS AUREUS; TREATMENT OUTCOME; VANCOMYCIN;

EID: 84902113734     PISSN: None     EISSN: 14712334     Source Type: Journal    
DOI: 10.1186/1471-2334-14-289     Document Type: Article

References (28)

1. Chu VH, Crosslin DR, Friedman JY, Reed SD, Cabell CH, Griffiths RI, Masselink LE, Kaye KS, Corey GR, Reller LB, Stryjewski ME, Schulman KA, Fowler VG. Staphylococcus aureus bacteremia in patients with prosthetic devices: costs and outcomes. Am J Med 2005, 118(12):1416.
2. Fowler VG, Olsen MK, Corey GR, Woods CW, Cabell CH, Reller LB, Cheng AC, Dudley T, Oddone EZ. Clinical identifiers of complicated Staphylococcus aureus bacteremia. Arch Intern Med 2003, 163(17):2066-2072. 10.1001/archinte.163.17.2066, 14504120.
3. Li Y, Friedman JY, O'Neal BF, Hohenboken MJ, Griffiths RI, Stryjewski ME, Middleton JP, Schulman KA, Inrig JK, Fowler VG, Reed SD. Outcomes of Staphylococcus aureus infection in hemodialysis-dependent patients. Clin J Am Soc Nephrol 2009, 4(2):428-434. 10.2215/CJN.03760708, 2637588, 19118117.
4. Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK, . Active Bacterial Core surveillance (ABCs) MRSA Investigators Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA 2007, 298(15):1763-1771. 10.1001/jama.298.15.1763, 17940231, Active Bacterial Core surveillance (ABCs) MRSA Investigators.
5. Deresinski S. Counterpoint: vancomycin and Staphylococcus aureus-an antibiotic enters obsolescence. Clin Infect Dis 2007, 44(12):1543-1548. 10.1086/518452, 17516396.
6. Sakoulas G, Moise-Broder PA, Schentag J, Forrest A, Moellering RC, Eliopoulos GM. Relationship of MIC and bactericidal activity to efficacy of vancomycin for treatment of methicillin-resistant Staphylococcus aureus bacteremia. J Clin Microbiol 2004, 42(6):2398-2402. 10.1128/JCM.42.6.2398-2402.2004, 427878, 15184410.
7. Soriano A, Marco F, Martínez JA, Pisos E, Almela M, Dimova VP, Alamo D, Ortega M, Lopez J, Mensa J. Influence of vancomycin minimum inhibitory concentration on the treatment of methicillin-resistant Staphylococcus aureus bacteremia. Clin Infect Dis 2008, 46(2):193-200. 10.1086/524667, 18171250.
8. Deresinski S. Vancomycin heteroresistance and methicillin-resistant Staphylococcus aureus. J Infect Dis 2009, 199(5):605-609. 10.1086/596630, 19199551.
9. Tenover FC. Vancomycin-resistant Staphylococcus aureus: a perfect but geographically limited storm?. Clin Infect Dis 2008, 46(5):675-677. 10.1086/527393, 18257701.
10. Chang FY, Peacock JE, Musher DM, Triplett P, MacDonald BB, Mylotte JM, O'Donnell A, Wagener MM, Yu VL. Staphylococcus aureus bacteremia: recurrence and the impact of antibiotic treatment in a prospective multicenter study. Medicine (Baltimore) 2003, 82(5):333-339. 10.1097/01.md.0000091184.93122.09, 14530782.
11. Stryjewski ME, Szczech LA, Benjamin DK, Inrig JK, Kanafani ZA, Engemann JJ, Chu VH, Joyce MJ, Reller LB, Corey GR, Fowler VG. Use of vancomycin or first-generation cephalosporins for the treatment of hemodialysis-dependent patients with methicillin-susceptible Staphylococcus aureus bacteremia. Clin Infect Dis 2007, 44(2):190-196. 10.1086/510386, 17173215.
12. Fowler VG, Boucher HW, Corey GR, Abrutyn E, Karchmer AW, Rupp ME, Levine DP, Chambers HF, Tally FP, Vigliani GA, Cabell CH, Link AS, De Meyer I, Filler SG, Zervos M, Cook P, Parsonnet J, Bernstein JM, Price CS, Forrest GN, Fätkenheuer G, Gareca M, Rehm SJ, Brodt HR, Tice A, Cosgrove SE, . S. aureus Endocarditis and Bacteremia Study Group Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med 2006, 355(7):653-665. 10.1056/NEJMoa053783, 16914701, S. aureus Endocarditis and Bacteremia Study Group.
13. Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF. Clinical practice guidelines by the infectious diseases society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis 2011, 52(3):285-292. 10.1093/cid/cir034, 21217178.
14. Hegde SS, Reyes N, Wiens T, Vanasse N, Skinner R, McCullough J, Kaniga K, Pace J, Thomas R, Shaw JP, Obedencio G, Judice JK. Pharmacodynamics of telavancin (TD-6424), a novel bactericidal agent, against gram-positive bacteria. Antimicrob Agents Chemother 2004, 48(8):3043-3050. 10.1128/AAC.48.8.3043-3050.2004, 478526, 15273119.
15. Higgins DL, Chang R, Debabov DV, Leung J, Wu T, Krause KM, Sandvik E, Hubbard JM, Kaniga K, Schmidt DE, Gao Q, Cass RT, Karr DE, Benton BM, Humphrey PP. Telavancin, a multifunctional lipoglycopeptide, disrupts both cell wall synthesis and cell membrane integrity in methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother 2005, 49(3):1127-1134. 10.1128/AAC.49.3.1127-1134.2005, 549257, 15728913.
16. Lunde CS, Hartouni SR, Janc JW, Mammen M, Humphrey PP, Benton BM. Telavancin disrupts the functional integrity of the bacterial membrane through targeted interaction with the cell wall precursor lipid II. Antimicrob Agents Chemother 2009, 53(8):3375-3383. 10.1128/AAC.01710-08, 2715647, 19470513.
17. Miró JM, García-de-la-Mària C, Armero Y, De-Lazzari E, Soy D, Moreno A, Del Rio A, Almela M, Mestres CA, Gatell JM, Jiménez-de-Anta MT, Marco F, . Hospital Clínic Experimental Endocarditis Study Group Efficacy of telavancin in the treatment of experimental endocarditis due to glycopeptide-intermediate Staphylococcus aureus. Antimicrob Agents Chemother 2007, 51(7):2373-2377. 10.1128/AAC.01266-06, 1913277, 17485502, Hospital Clínic Experimental Endocarditis Study Group.
18. Leuthner KD, Cheung CM, Rybak MJ. Comparative activity of the new lipoglycopeptide telavancin in the presence and absence of serum against 50 glycopeptide non-susceptible staphylococci and three vancomycin-resistant Staphylococcus aureus. J Antimicrob Chemother 2006, 58(2):338-343. 10.1093/jac/dkl235, 16787952.
19. Hegde SS, Skinner R, Lewis SR, Krause KM, Blais J, Benton BM. Activity of telavancin against heterogeneous vancomycin-intermediate Staphylococcus aureus (hVISA) in vitro and in an in vivo mouse model of bacteraemia. J Antimicrob Chemother 2010, 65(4):725-728. 10.1093/jac/dkq028, 20139142.
20. Madrigal AG, Basuino L, Chambers HF. Efficacy of Telavancin in a rabbit model of aortic valve endocarditis due to methicillin-resistant Staphylococcus aureus or vancomycin-intermediate Staphylococcus aureus. Antimicrob Agents Chemother 2005, 49(8):3163-3165. 10.1128/AAC.49.8.3163-3165.2005, 1196289, 16048918.
21. Marcos LA, Camins BC. Successful treatment of vancomycin-intermediate Staphylococcus aureus pacemaker lead infective endocarditis with telavancin. Antimicrob Agents Chemother 2010, 54(12):5376-5378. 10.1128/AAC.00857-10, 2981253, 20876369.
22. Nace H, Lorber B. Successful treatment of methicillin-resistant Staphylococcus aureus endocarditis with telavancin. J Antimicrob Chemother 2010, 65(6):1315-1316. 10.1093/jac/dkq113, 20375035.
23. Agresti A, Caffo B. Simple and effective confidence intervals for proportions and differences of proportions result from adding two successes and two failures. Am Stat 2000, 54(4):280-288.
24. Skinner D, Keefer CS. Significance of bacteremia caused by Staphylococcus aureus: a study of one hundred and twenty-two cases and a review of the literature concerned with experimental infection in animals. Arch Intern Med 1941, 68(5):851-875.
25. Hawkins C, Huang J, Jin N, Noskin GA, Zembower TR, Bolon M. Persistent Staphylococcus aureus bacteremia: an analysis of risk factors and outcomes. Arch Intern Med 2007, 167(17):1861-1867. 10.1001/archinte.167.17.1861, 17893307.
26. Jensen AG, Wachmann CH, Espersen F, Scheibel J, Skinhoj P, Frimodt-Møller N. Treatment and outcome of Staphylococcus aureus bacteremia: a prospective study of 278 cases. Arch Intern Med 2002, 162(1):25-32. 10.1001/archinte.162.1.25, 11784216.
27. 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. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis 2008, 46(11):1683-1693. 10.1086/587896, 18444791.
28. Bauer KA, West JE, Balada-Llasat JM, Pancholi P, Stevenson KB, Goff DA. An antimicrobial stewardship program's impact with rapid polymerase chain reaction methicillin-resistant Staphylococcus aureus/S. aureus blood culture test in patients with S. aureus bacteremia. Clin Infect Dis 2010, 51(9):1074-1080. 10.1086/656623, 20879856.