CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: Study protocol for a randomised controlled trial

Trials

Volumn 17, Issue 1, 2016, Pages

  Tong, Steven Y C ^a,b   Nelson, Jane ^a   Paterson, David L ^c   Fowler, Vance G ^d   Howden, Benjamin P ^e   Cheng, Allen C ^f,g   Chatfield, Mark ^a   Lipman, Jeffrey ^c,h   Van Hal, Sebastian ⁱ   O'Sullivan, Matthew ^j,k   Robinson, James O ^l,m   Yahav, Dafna ^n,o   Lye, David ^p,q   Davis, Joshua S ^a,r  

^a MENZIES SCHOOL OF HEALTH RESEARCH   (Australia)

^b ROYAL DARWIN HOSPITAL   (Australia)

^c UNIVERSITY OF QUEENSLAND   (Australia)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e UNIVERSITY OF MELBOURNE   (Australia)

^f ALFRED HEALTH   (Australia)

^g MONASH UNIVERSITY   (Australia)

^h QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

ⁱ ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^j WESTMEAD HOSPITAL   (Australia)

^k University of Sydney   (Australia)

^l FIONA STANLEY HOSPITAL   (Australia)

^m MURDOCH UNIVERSITY   (Australia)

ⁿ TEL AVIV UNIVERSITY   (Israel)

^o RABIN MEDICAL CENTER   (Israel)

^p TAN TOCK SENG HOSPITAL   (Singapore)

^q NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^r JOHN HUNTER HOSPITAL   (Australia)

more..

Author keywords

Cefazolin; Cloxacillin; Combination; Daptomycin; Flucloxacillin; Methicillin resistant; MRSA; Nafcillin; Randomised controlled trial; Staphylococcus aureus; Vancomycin

Indexed keywords

CEFAZOLIN; CLOXACILLIN; DAPTOMYCIN; FLUCLOXACILLIN; PENICILLIN DERIVATIVE; VANCOMYCIN; ANTIINFECTIVE AGENT; BETA LACTAM;

ADULT; ANTIBIOTIC THERAPY; ARTICLE; AUSTRALIA; BACTERIAL LOAD; BLOOD CULTURE; CONTROLLED STUDY; DRUG COST; DRUG SAFETY; HEALTH CARE AVAILABILITY; HUMAN; ISRAEL; MAJOR CLINICAL STUDY; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION; MORTALITY; NEW ZEALAND; OPEN STUDY; PARALLEL DESIGN; RANDOMIZED CONTROLLED TRIAL; RELAPSE; SINGAPORE; TREATMENT DURATION; TREATMENT FAILURE; TREATMENT OUTCOME; CLINICAL PROTOCOL; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DRUG EFFECTS; ISOLATION AND PURIFICATION; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; METHODOLOGY; MICROBIOLOGY; MULTICENTER STUDY; PATHOGENICITY; PENICILLIN RESISTANCE; STAPHYLOCOCCAL INFECTIONS; TIME FACTOR;

ANTI-BACTERIAL AGENTS; AUSTRALIA; BETA-LACTAMS; CEFAZOLIN; CLINICAL PROTOCOLS; CLOXACILLIN; DAPTOMYCIN; DRUG THERAPY, COMBINATION; FLOXACILLIN; HUMANS; ISRAEL; METHICILLIN RESISTANCE; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; NEW ZEALAND; RESEARCH DESIGN; SINGAPORE; STAPHYLOCOCCAL INFECTIONS; TIME FACTORS; TREATMENT OUTCOME; VANCOMYCIN;

EID: 85007504277     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/S13063-016-1295-3     Document Type: Article

References (65)

1. Tong SYC, Davis JS, Eichenberger E, Holland TL, Fowler VG. Staphylococcus aureus infections: epidemiology, pathophysiology, clinical manifestations, and management. Clin Microbiol Rev. 2015;28:603-61.
2. Turnidge JD, Kotsanas D, Munckhof W, Roberts S, Bennett CM, Nimmo GR, et al. Staphylococcus aureus bacteraemia: a major cause of mortality in Australia and New Zealand. Med J Aust. 2009;191:368-73.
3. Dantes R, Mu Y, Belflower R, Aragon D, Dumyati G, Harrison LH, et al. National burden of invasive methicillin-resistant Staphylococcus aureus infections, United States, 2011. JAMA Intern Med. 2013;173:1970-8.
4. Cosgrove SE, Sakoulas G, Perencevich EN, Schwaber MJ, Karchmer AW, Carmeli Y. Comparison of mortality associated with methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteraemia: a meta-analysis. Clin Infect Dis. 2003;36:53-9.
5. Nickerson EK, Hongsuwan M, Limmathurotsakul D, Wuthiekanun V, Shah KR, Srisomang P, et al. Staphylococcus aureus bacteraemia in a tropical setting: patient outcome and impact of antibiotic resistance. PLoS One. 2009;4:e4308.
6. Small PM, Chambers HF. Vancomycin for Staphylococcus aureus endocarditis in intravenous drug users. Antimicrob Agents Chemother. 1990;34:1227-31.
7. Rybak MJ. The pharmacokinetic and pharmacodynamic properties of vancomycin. Clin Infect Dis. 2006;42 Suppl 1:S35-9.
8. Gentry CA, Rodvold KA, Novak RM, Hershow RC, Naderer OJ. Retrospective evaluation of therapies for Staphylococcus aureus endocarditis. Pharmacotherapy. 1997;17:990-7.
9. Geraci JE, Wilson WR. Vancomycin therapy for infective endocarditis. Rev Infect Dis. 1981;3(Suppl):S250-8.
10. Lodise Jr TP, McKinnon PS, Levine DP, Rybak MJ. Impact of empiricaltherapy selection on outcomes of intravenous drug users with infective endocarditis caused by methicillin-susceptible Staphylococcus aureus. Antimicrob Agents Chemother. 2007;51:3731-3.
11. Kollef MH. Limitations of vancomycin in the management of resistant staphylococcal infections. Clin Infect Dis. 2007;45:S191-S5.
12. Howden BP, Peleg AY, Stinear TP. The evolution of vancomycin intermediate Staphylococcus aureus (VISA) and heterogenous-VISA. Infect Genet Evol. 2014;21:575-82.
13. Mohr JF, Murray BE. Point: vancomycin is not obsolete for the treatment of infection caused by methicillin-resistant Staphylococcus aureus. Clin Infect Dis. 2007;44:1536-42.
14. van Hal SJ, Fowler Jr VG. Is it time to replace vancomycin in the treatment of methicillin-resistant Staphylococcus aureus infections? Clin Infect Dis. 2013;56:1779-88.
15. Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, et al. 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:e18-55.
16. Antibiotic Expert Group. Therapeutic guidelines: Antibiotic. Version 15, 2014. Melbourne: Therapeutic Guidelines Limited; 2014.
17. Abbott IJ, Jenney AW, Jeremiah CJ, Mirceta M, Kandiah JP, Holt DC, et al. Reduced in-vitro activity of ceftaroline by Etest among CC239 methicillinresistant Staphylococcus aureus (MRSA) clinical strains from Australia. Antimicrob Agents Chemother. 2015.
18. Nguyen HM, Graber CJ. Limitations of antibiotic options for invasive infections caused by methicillin-resistant Staphylococcus aureus: is combination therapy the answer? J Antimicrob Chemother. 2010;65:24-36.
19. Deresinski S. Vancomycin in combination with other antibiotics for the treatment of serious methicillin-resistant Staphylococcus aureus infections. Clin Infect Dis. 2009;49:1072-9.
20. Steinkraus G, White R, Friedrich L. Vancomycin MIC creep in nonvancomycin-intermediate Staphylococcus aureus (VISA), vancomycinsusceptible clinical methicillin-resistant S. aureus (MRSA) blood isolates from 2001-05. J Antimicrob Chemother. 2007;60:788-94.
21. Davis JS, Hal SV, Tong SY. Combination antibiotic treatment of serious methicillinresistant Staphylococcus aureus infections. Semin Respir Crit Care Med. 2015;36:3-16.
22. Seibert G, Isert D, Klesel N, Limbert M, Markus A, Schrinner E. The in-vitro antibacterial activity of a combination of cefpirome or cefoperazone with vancomycin against enterococci and Staphylococcus aureus. J Antimicrob Chemother. 1992;29(Suppl A):25-30.
23. Palmer SM, Rybak MJ. An evaluation of the bactericidal activity of ampicillin/sulbactam, piperacillin/tazobactam, imipenem or nafcillin alone and in combination with vancomycin against methicillin-resistant Staphylococcus aureus (MRSA) in time-kill curves with infected fibrin clots. J Antimicrob Chemother. 1997;39:515-8.
24. Climo MW, Patron RL, Archer GL. Combinations of vancomycin and betalactams are synergistic against staphylococci with reduced susceptibilities to vancomycin. Antimicrob Agents Chemother. 1999;43:1747-53.
25. Lozniewski A, Lion C, Mory F, Weber M. In vitro synergy between cefepime and vancomycin against methicillin-susceptible and-resistant Staphylococcus aureus and Staphylococcus epidermidis. J Antimicrob Chemother. 2001;47:83-6.
26. Domaracki BE, Evans AM, Venezia RA. Vancomycin and oxacillin synergy for methicillin-resistant staphylococci. Antimicrob Agents Chemother. 2000;44:1394-6.
27. Drago L, De Vecchi E, Nicola L, Gismondo MR. In vitro evaluation of antibiotics' combinations for empirical therapy of suspected methicillin resistant Staphylococcus aureus severe respiratory infections. BMC Infect Dis. 2007;7:111.
28. Kobayashi Y. Study of the synergism between carbapenems and vancomycin or teicoplanin against MRSA, focusing on S-4661, a carbapenem newly developed in Japan. J Infect Chemother. 2005;11: 259-61.
29. Ribes S, Pachon-Ibanez ME, Dominguez MA, Fernandez R, Tubau F, Ariza J, et al. In vitro and in vivo activities of linezolid alone and combined with vancomycin and imipenem against Staphylococcus aureus with reduced susceptibility to glycopeptides. Eur J Clin Microbiol Infect Dis. 2010;29:1361-7.
30. Joukhadar C, Pillai S, Wennersten C, Moellering Jr RC, Eliopoulos GM. Lack of bactericidal antagonism or synergism in vitro between oxacillin and vancomycin against methicillin-susceptible strains of Staphylococcus aureus. Antimicrob Agents Chemother. 2010;54:773-7.
31. Silva LV, Araujo MT, Santos KR, Nunes AP. Evaluation of the synergistic potential of vancomycin combined with other antimicrobial agents against methicillin-resistant Staphylococcus aureus and coagulase-negative Staphylococcus spp strains. Mem Inst Oswaldo Cruz. 2011;106:44-50.
32. Hagihara M, Wiskirchen DE, Kuti JL, Nicolau DP. In vitro pharmacodynamics of vancomycin and cefazolin alone and in combination against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2012;56:202-7.
33. Fernandez J, Abbanat D, Shang W, He W, Amsler K, Hastings J, et al. Synergistic activity of ceftobiprole and vancomycin in a rat model of infective endocarditis caused by methicillin-resistant and glycopeptideintermediate Staphylococcus aureus. Antimicrob Agents Chemother. 2012;56: 1476-84.
34. Leonard SN. Synergy between vancomycin and nafcillin against Staphylococcus aureus in an in vitro pharmacokinetic/pharmacodynamic model. PLoS One. 2012;7:e42103.
35. Dilworth TJ, Sliwinski J, Ryan K, Dodd M, Mercier RC. Evaluation of vancomycin in combination with piperacillin-tazobactam or oxacillin against clinical methicillin-resistant Staphylococcus aureus isolates and vancomycin-intermediate Staphylococcus aureus isolates in vitro. Antimicrob Agents Chemother. 2013; 58(2):1028-33.
36. Werth BJ, Steed ME, Kaatz GW, Rybak MJ. Evaluation of ceftaroline activity against heteroresistant vancomycin-intermediate Staphylococcus aureus and vancomycin-intermediate methicillin-resistant S. aureus strains in an in vitro pharmacokinetic/pharmacodynamic model: exploring the 'seesaw effect'. Antimicrob Agents Chemother. 2013;57:2664-8.
37. Werth BJ, Vidaillac C, Murray KP, Newton KL, Sakoulas G, Nonejuie P, et al. Novel combinations of vancomycin plus ceftaroline or oxacillin against methicillin-resistant vancomycin-intermediate Staphylococcus aureus (VISA) and heterogeneous VISA. Antimicrob Agents Chemother. 2013;57:2376-9.
38. Davis JS, Sud A, O'Sullivan MV, Robinson JO, Ferguson PE, Foo H, et al. Combination of vancomycin and beta-lactam therapy for methicillinresistant Staphylococcus aureus bacteraemia: a pilot multicenter randomised controlled trial. Clin Infect Dis. 2015;62(2): 173-80.
39. Snydman DR, McDermott LA, Jacobus NV. Evaluation of in vitro interaction of daptomycin with gentamicin or beta-lactam antibiotics against Staphylococcus aureus and enterococci by FIC index and timed-kill curves. J Chemother. 2005;17:614-21.
40. Silva M, Jacobus NV, Gorbach SL. In vitro activity of LY146032 against grampositive bacteria. Diagn Microbiol Infect Dis. 1988;9:79-85.
41. Rand KH, Houck HJ. Synergy of daptomycin with oxacillin and other betalactams against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2004;48:2871-5.
42. Tsuji BT, Rybak MJ. Etest synergy testing of clinical isolates of Staphylococcus aureus demonstrating heterogeneous resistance to vancomycin. Diagn Microbiol Infect Dis. 2006;54:73-7.
43. Mehta S, Singh C, Plata KB, Chanda PK, Paul A, Riosa S, et al. beta-Lactams increase the antibacterial activity of daptomycin against clinical methicillinresistant Staphylococcus aureus strains and prevent selection of daptomycinresistant derivatives. Antimicrob Agents Chemother. 2012;56:6192-200.
44. Cilli F, Aydemir S, Tunger A. In vitro activity of daptomycin alone and in combination with various antimicrobials against Gram-positive cocci. J Chemother. 2006;18:27-32.
45. Barber KE, Werth BJ, Ireland CE, Stone NE, Nonejuie P, Sakoulas G, et al. Potent synergy of ceftobiprole plus daptomycin against multiple strains of Staphylococcus aureus with various resistance phenotypes. J Antimicrob Chemother. 2014;69:3006-10.
46. Leonard SN, Rolek KM. Evaluation of the combination of daptomycin and nafcillin against vancomycin-intermediate Staphylococcus aureus. J Antimicrob Chemother. 2013;68:644-7.
47. Rose WE, Schulz LT, Andes D, Striker R, Berti AD, Hutson PR, et al. Addition of ceftaroline to daptomycin after emergence of daptomycinnonsusceptible Staphylococcus aureus during therapy improves antibacterial activity. Antimicrob Agents Chemother. 2012;56:5296-302.
48. Werth BJ, Barber KE, Ireland CE, Rybak MJ. Evaluation of ceftaroline, vancomycin, daptomycin, or ceftaroline plus daptomycin against daptomycin-nonsusceptible methicillin-resistant Staphylococcus aureus in an in vitro pharmacokinetic/pharmacodynamic model of simulated endocardial vegetations. Antimicrob Agents Chemother. 2014;58:3177-81.
49. Werth BJ, Sakoulas G, Rose WE, Pogliano J, Tewhey R, Rybak MJ. Ceftaroline increases membrane binding and enhances the activity of daptomycin against daptomycin-nonsusceptible vancomycin-intermediate Staphylococcus aureus in a pharmacokinetic/pharmacodynamic model. Antimicrob Agents Chemother. 2013;57:66-73.
50. Garrigos C, Murillo O, Lora-Tamayo J, Verdaguer R, Tubau F, Cabellos C, et al. Efficacy of daptomycin-cloxacillin combination in experimental foreign-body infection due to methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2012;56:3806-11.
51. Dhand A, Bayer AS, Pogliano J, Yang SJ, Bolaris M, Nizet V, et al. Use of antistaphylococcal beta-lactams to increase daptomycin activity in eradicating persistent bacteraemia due to methicillin-resistant Staphylococcus aureus: role of enhanced daptomycin binding. Clin Infect Dis. 2011;53:158-63.
52. Sakoulas G, Moise PA, Casapao AM, Nonejuie P, Olson J, Okumura CY, et al. Antimicrobial salvage therapy for persistent staphylococcal bacteraemia using daptomycin plus ceftaroline. Clin Ther. 2014;36:1317-33.
53. Ortwine JK, Werth BJ, Sakoulas G, Rybak MJ. Reduced glycopeptide and lipopeptide susceptibility in Staphylococcus aureus and the 'seesaw effect': taking advantage of the back door left open? Drug Resist Updat. 2013;16:73-9.
54. Adhikari RP, Scales GC, Kobayashi K, Smith JM, Berger-Bachi B, Cook GM. Vancomycin-induced deletion of the methicillin resistance gene mecA in Staphylococcus aureus. J Antimicrob Chemother. 2004;54:360-3.
55. Sieradzki K, Wu SW, Tomasz A. Inactivation of the methicillin resistance gene mecA in vancomycin-resistant Staphylococcus aureus. Microb Drug Resist. 1999;5:253-7.
56. Sakoulas G, Okumura CY, Thienphrapa W, Olson J, Nonejuie P, Dam Q, et al. Nafcillin enhances innate immune-mediated killing of methicillin-resistant Staphylococcus aureus. J Mol Med (Berl). 2014;92:139-49.
57. Rybak M, Lomaestro B, Rotschafer JC, Moellering Jr R, Craig W, Billeter M, et al. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009;66:82-98.
58. Thwaites G, Auckland C, Barlow G, Cunningham R, Davies G, Edgeworth J, et al. Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemia (ARREST): study protocol for a randomised controlled trial. Trials. 2012;13:241.
59. Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, et al. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11:R31.
60. Burgess LD, Drew RH. Comparison of the incidence of vancomycin-induced nephrotoxicity in hospitalized patients with and without concomitant piperacillin-tazobactam. Pharmacotherapy. 2014;34:670-6.
61. Gomes DM, Smotherman C, Birch A, Dupree L, Della Vecchia BJ, Kraemer DF, et al. Comparison of acute kidney injury during treatment with vancomycin in combination with piperacillin-tazobactam or cefepime. Pharmacotherapy. 2014;34:662-9.
62. Fowler Jr VG, Boucher HW, Corey GR, Abrutyn E, Karchmer AW, Rupp ME, et al. Daptomycin versus standard therapy for bacteraemia and endocarditis caused by Staphylococcus aureus. N Engl J Med. 2006;355:653-65.
63. Holmes NE, Turnidge JD, Munckhof WJ, Robinson JO, Korman TM, O'Sullivan MV, et al. Antibiotic choice may not explain poorer outcomes in patients with Staphylococcus aureus bacteraemia and high vancomycin minimum inhibitory concentrations. J Infect Dis. 2011;204:340-7.
64. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline: guideline for Good Clinical Practice. J Postgrad Med. 2001;47:45-50.
65. Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, et al. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007;298:1763-71.