A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria

International Journal of Clinical Practice

Volumn 62, Issue 9, 2008, Pages 1455-1464

  Katz, D E ^a   Lindfield, K C ^a   Steenbergen, J N ^a   Benziger, D P ^a   Blackerby, K J ^a   Knapp, A G ^a   Martone, W J ^a  

^a CUBIST PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DAPTOMYCIN; PENICILLIN G; VANCOMYCIN;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASTHENIA; BACTERIAL INFECTION; CLINICAL TRIAL; COMORBIDITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DEMOGRAPHY; DIZZINESS; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ERYTHEMA; FEMALE; FEVER; GASTROINTESTINAL DISEASE; GRAM POSITIVE BACTERIUM; HOSPITALIZATION; HUMAN; HYPOKALEMIA; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; MULTICENTER STUDY; NAUSEA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE BLIND PROCEDURE; SKIN INFECTION; STAPHYLOCOCCUS INFECTION; UNSPECIFIED SIDE EFFECT; VOMITING;

ADULT; ANTI-BACTERIAL AGENTS; DAPTOMYCIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; GRAM-POSITIVE BACTERIAL INFECTIONS; HUMANS; MALE; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; PILOT PROJECTS; SINGLE-BLIND METHOD; SKIN DISEASES, BACTERIAL; STAPHYLOCOCCAL SKIN INFECTIONS; TREATMENT OUTCOME;

EID: 49349113640     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/j.1742-1241.2008.01854.x     Document Type: Article

References (43)

1. Diekema DJ, Pfaller MA, Schmitz FJ et al. Survey of infections due to Staphylococcus species: frequency of occurrence and antimicrobial susceptibility of isolates collected in the United States, Canada, Latin America, Europe, and the Western Pacific region for the SENTRY Antimicrobial Surveillance Program, 1997-1999. Clin Infect Dis 2001 32: S114 32.
2. Rennie RP, Jones RN, Mutnick AH. Occurrence and antimicrobial susceptibility patterns of pathogens isolated from skin and soft tissue infections: report from the SENTRY Antimicrobial Surveillance Program (United States and Canada, 2000). Diagn Microbiol Infect Dis 2003 45: 287 93.
3. Klevens RM, Morrison MA, Nadle J et al. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. J Amer Med Assoc 2007 298: 1763 71.
4. Moran GJ, Krishnadasan A, Gorwitz RJ et al. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med 2006 355: 666 74.
5. Al-Rawahi GN, Reynolds S, Porter SD et al. Community-associated CMRSA-10 (USA-300) is the predominant strain among methicillin-resistant Staphylococcus aureus strains causing skin and soft tissue infections in patients presenting to the Emergency Department of a Canadian Tertiary Care Hospital. J Emerg Med 2008, in press.
6. Centers for Disease Control and Prevention (CDC). Methicillin (oxacillin)-resistant Staphylococcus aureus(MRSA) among ICU Patients, 1995-2004 [internet]. Atlanta (GA): Centers for Disease Control and Prevention 2006 [cited 2008 Jun 12]. Available from: http://www.cdc.gov/ncidod/dhqp/pdf/ar/ ICU_RESTrend1995-2004.pdf.
7. Klevens RM, Edwards JR, Tenover FC et al. Changes in the epidemiology of methicillin-resistant Staphylococcus aureus in intensive care units in US hospitals, 1992-2003. Clin Infect Dis 2006 42: 389 91.
8. Fuchs PC, Barry AL, Brown SD. In vitro bactericidal activity of daptomycin against staphylococci. J Antimicrob Chemother 2002 49: 467 70.
9. Mortin LI, Li T, Van Praagh AD et al. Rapid bactericidal activity of daptomycin against methicillin-resistant and methicillin-susceptible Staphylococcus aureus peritonitis in mice as measured with bioluminescent bacteria. Antimicrob Agents Chemother 2007 51: 1787 94.
10. Arbeit RD, Maki D, Tally FP et al. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis 2004 38: 1673 81.
11. Fowler VG Jr., Boucher HW, Corey R et al. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med 2006 355: 653 65.
12. Krige JE, Lindfield K, Friedrich L et al. Effectiveness and duration of daptomycin therapy in resolving clinical symptoms in the treatment of complicated skin and skin structure infections. Curr Med Res Opin 2007 23: 2147 56.
13. Akins RL, Rybak MJ. Bactericidal activities of two daptomycin regimens against clinical strains of glycopeptide intermediate-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and methicillin-resistant Staphylococcus aureus isolates in an in vitro pharmacodynamic model with simulated endocardial vegetations. Antimicrob Agents Chemother 2001 45: 454 9.
14. Thorne GM, Alder J. Daptomycin: a novel lipopeptide antibiotic. Clin Microbio Newsletter 2002 24: 33 40.
15. Rose WE, Leonard SN, Sakoulas G et al. Daptomycin activity against Staphylococcus aureus following vancomycin exposure in an in vitro pharmacodynamic model with simulated endocardial vegetations. Antimicrob Agents Chemother 2008 52: 831 6.
16. Rose WE, Rybak MJ, Kaatz GW. Evaluation of daptomycin treatment of Staphylococcus aureus bacterial endocarditis: an in vitro and in vivo simulation using historical and current dosing strategies. J Antimicrob Chemother 2007 60: 334 40.
17. Firsov AA, Smirnova MV, Lubenko IY et al. Testing the mutant selection window hypothesis with Staphylococcus aureus exposed to daptomycin and vancomycin in an in vitro dynamic model. J Antimicrob Chemother 2006 58: 1185 92.
18. Benvenuto M, Benziger DP, Yankelev S et al. Pharmacokinetics and tolerability of daptomycin at doses up to 12 mg per kilogram of body weight once daily in healthy volunteers. Antimicrob Agents Chemother 2006 50: 3245 9.
19. Figueroa DA, Mangini E, Amodio-Groton M et al. Clinical Safety with Daptomycin at Doses Greater than 6 mg/kg. Poster session presented at: 47th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2007 Sep 17-20 Chicago, IL.
20. Levine DP, Lamp KC. Daptomycin in the treatment of patients with infective endocarditis: experience from a registry. Am J Med 2007 120: S28 33.
21. Sakoulas G, Golan Y, Lamp KC et al. Daptomycin in the treatment of bacteremia. Am J Med 2007 120: S21 7.
22. Nichols RL. Optimal treatment of complicated skin and skin structure infections. J Antimicrob Chemother 1999 44: 19 23.
23. U.S. Department of Health and Human Services, Food and Drug Administration (FDA). Guidance for Industry: Uncomplicated and Complicated Skin and Skin Structure Infections - Developing Antimicrobial Drugs for Treatment (Draft Guidance). Rockville, MD: U.S. Department of Health and Human Services, 1998, July Report No.: HFD-210.
24. Kim H. Semi-single versus double-blind design? Good Clin Pract J 2006 13: 16 7.
25. Chan IS, Zhang Z. Test-based exact confidence intervals for the difference of two binomial proportions. Biometrics 1999 55: 1202 9.
26. Tice AD, Rehm SJ, Dalovisio JR et al. Practice guidelines for outpatient parenteral antimicrobial therapy. IDSA guidelines. Clin Infect Dis 2004 38: 1651 72.
27. Lee MC, Rios AM, Aten MF et al. Management and outcome of children with skin and soft tissue abscesses caused by community-acquired methicillin- resistant Staphylococcus aureus. Pediatr Infect Dis J 2004 23: 123 7.
28. Korownyk C, Allan GM. Evidence-based approach to abscess management. Can Fam Physician 2007 53: 1680 4.
29. Kopp BJ, Nix DE, Armstrong EP. Clinical and economic analysis of methicillin-susceptible and -resistant Staphylococcus aureus infections. Ann Pharmacother 2004 38: 1377 82.
30. Cosgrove SE, Qi Y, Kaye KS et al. The impact of methicillin resistance in Staphylococcus aureus bacteremia on patient outcomes: mortality, length of stay, and hospital charges. Infect Control Hosp Epidemiol 2005 26: 166 74.
31. Whitby M, McLaws ML, Berry G. Risk of death from methicillin-resistant Staphylococcus aureus bacteraemia: a meta-analysis. Med J Aust 2001 175: 264 7.
32. Shurland S, Zhan M, Bradham DD et al. Comparison of mortality risk associated with bacteremia due to methicillin-resistant and methicillin- susceptible Staphylococcus aureus. Infect Control Hosp Epidemiol 2007 28: 273 9.
33. Engemann JJ, Carmeli Y, Cosgrove SE et al. Adverse clinical and economic outcomes attributable to methicillin resistance among patients with Staphylococcus aureus surgical site infection. Clin Infect Dis 2003 36: 592 8.
34. Rybak MJ, Abate BJ, Kang SL et al. Prospective evaluation of the effect of an aminoglycoside dosing regimen on rates of observed nephrotoxicity and ototoxicity. Antimicrob Agents Chemother 1999 43: 1549 55.
35. Barclay ML, Begg EJ, Hickling KG. What is the evidence for once-daily aminoglycoside therapy? Clin Pharmacokinet 1994 27: 32 48.
36. Freeman CD, Nicolau DP, Belliveau PP et al. Once-daily dosing of aminoglycosides: review and recommendations for clinical practice. J Antimicrob Chemother 1997 39: 677 86.
37. American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med 2005 171: 388 416.
38. Biner B, Celtik C, Oner N et al. The comparison of single-dose ceftriaxone, five-day azithromycin, and ten-day amoxicillin/clavulanate for the treatment of children with acute otitis media. Turk J Pediatr 2007 49: 390 6.
39. Guay D. Short-course antimicrobial therapy of respiratory tract infections. Drugs 2003 63: 2169 84.
40. Schrag SJ, Peña C, Fernández J et al. Effect of short-course, high-dose amoxicillin therapy on resistant pneumococcal carriage: a randomized trial. J Amer Med Assoc 2001 286: 49 56.
41. Li JZ, Winston LG, Moore DH et al. Efficacy of short-course antibiotic regimens for community-acquired pneumonia: a meta-analysis. Am J Med 2007 120: 783 90.
42. Drusano GL, Louie A, Deziel M et al. The crisis of resistance: identifying drug exposures to suppress amplification of resistant mutant subpopulations. Clin Infect Dis 2006 42: 525 32.
43. Drlica K, Zhao X. Mutant selection window hypothesis updated. Clin Infect Dis 2007 44: 681 8.