The Way Forward: High-Dose, Short-Course Levofloxacin Leads the Field

29 March, 2018

References

1. Levaquin(R) (levofloxacin) [package insert]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc., September 2008.
2. Gotfried MH, Danziger LH, Rodvold KA. Steady-state plasma and intrapulmonary concentrations of levofloxacin and ciprofloxacin in healthy adult subjects. Chest 2001; 119: 1114-22.
3. Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis 1998; 26: 1-10.
4. Craig WA. Does the dose matter? Clin Infect Dis 2001; 33 (Suppl3): S233-7.
5. Wright DH, Brown GH, Peterson ML, Rotschafer JC. Application of fluoroquinolone pharmacodynamics. J Antimicrob Chemother 2000; 46: 669-83.
6. Nightingale CH, Grant EM, Quintiliani R. Pharmacodynamics and pharmacokinetics of levofloxacin. Chemotherapy 2000; 46 (Suppl1): 6-14.
7. Bartlett JB. Management of respiratory tract infections. 3rd ed, Philadelphia: Lippincott Williams & Wilkins, 2001.
8. Ambrose PG, Grasela DM, Grasela TH, Passarell J, Mayer HB, Pierce PF. Pharmacodynamics of fluoroquinolones against Streptococcus pneumoniae in patients with community-acquired respiratory tract infections. Antimicrob Agents Chemother 2001; 45: 2793-7.
9. Noreddin AM, Marras TK, Sanders K, Chan CK, Hoban DJ, Zhanel GG. Pharmacodynamic target attainment analysis against Streptococcus pneumoniae using levofloxacin 500 mg, 750 mg and 1000 mg once daily in plasma (P) and epithelial lining fluid (ELF) of hospitalized patients with community acquired pneumonia (CAP). Int J Antimicrob Agents 2004; 24: 479-84.
10. Noreddin AM, Hoban DJ, Zhanel GG. Comparison of gatifloxacin and levofloxacin administered at various dosing regimens to hospitalised patients with community-acquired pneumonia: pharmacodynamic target attainment study using North American surveillance data for Streptococcus pneumoniae. Int J Antimicrob Agents 2005; 26: 120-5.
11. Zhanel GG, Roberts D, Waltky A, Laing N, Nichol K, Smith H, Noreddin A, Bellyou T, Hoban DJ. Pharmacodynamic activity of fluoroquinolones against ciprofloxacin-resistant Streptococcus pneumoniae. J Antimicrob Chemother 2002; 49: 807-12.
12. Drusano GL. Pharmacokinetics and pharmacodynamics of antimicrobials. Clin Infect Dis 2007; 45 (Suppl 1): S89-95.
13. Drusano GL, Preston SL, Fowler C, Corrado M, Weisinger B, Kahn J. Relationship between fluoroquinolone area under the curve: minimum inhibitory concentration ratio and the probability of eradication of the infecting pathogen, in patients with nosocomial pneumonia. J Infect Dis 2004; 189: 1590-7.
14. Lister PD. Pharmacodynamics of 750 mg and 500 mg doses of levofloxacin against ciprofloxacin-resistant strains of Streptococcus pneumoniae. Diagn Microbiol Infect Dis 2002; 44: 43-9.
15. Huband MD, Cohen MA, Zurack M, Hanna DL, Skerlos LA, Sulavik MC, Gibson GW, Gage JW, Ellsworth E, Stier MA, Gracheck SJ. In vitro and in vivo activities of PD 0305970 and PD 0326448, new bacterial gyrase/topoisomerase inhibitors with potent antibacterial activities versus multidrug-resistant Gram-positive and fastidious organism groups. Antimicrob Agents Chemother 2007; 51: 1191-201.
16. Huband MD, Brighty KE, Monohan R, et al. In vitro antibacterial activity of CE-156811, CP-919474, and CP-929898: novel hygromycin A analogs compared to levofloxacin and other antibacterial agents against 1220 recent clinical isolates [abstract No. F1-1963]. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 2007; San Francisco, California.
17. Nilius AM, Shen LL, Hensey-Rudloff D, Almer LS, Beyer JM, Balli DJ, Cai Y, Flamm RK. In vitro antibacterial potency and spectrum of ABT-492, a new fluoroquinolone. Antimicrob Agents Chemother 2003; 47: 3260-9.
18. Blondeau JM, Laskowski R, Bjarnason J, Stewart C. Comparative in vitro activity of gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin and trovafloxacin against 4151 Gram-negative and Gram-positive organisms. Int J Antimicrob Agents 2000; 14: 45-50.
19. Deshpande LM, Diekema DJ, Jones RN. Comparative activity of clinafloxacin and nine other compounds tested against 2000 contemporary clinical isolates from patients in United States hospitals. Diagn Microbiol Infect Dis 1999; 35: 81-8.
20. Rolston KV, Frisbee-Hume S, LeBlanc BM, Streeter H, Ho DH. Antimicrobial activity of a novel des-fluoro (6) quinolone, garenoxacin (BMS-284756), compared to other quinolones, against clinical isolates from cancer patients. Diagn Microbiol Infect Dis 2002; 44: 187-94.
21. Fritsche TR, Sader HS, Jones RN. Potency and spectrum of garenoxacin tested against an international collection of skin and soft tissue infection pathogens: report from the SENTRY antimicrobial surveillance program (1999-2004). Diagn Microbiol Infect Dis 2007; 58: 19-26.
22. Goff DA, Dowzicky MJ. Prevalence and regional variation in meticillinresistant Staphylococcus aureus (MRSA) in the USA and comparative in vitro activity of tigecycline, a glycylcycline antimicrobial. J Med Microbiol 2007; 56: 1189-93.
23. Gordon KA, Sader HS, Jones RN. Contemporary re-evaluation of the activity and spectrum of grepafloxacin tested against isolates in the United States. Diagn Microbiol Infect Dis 2003; 47: 377-83.
24. Jones RN, Fritsche TR, Sader HS, Stilwell MG. Activity of garenoxacin, an investigational des- F(6)-quinolone, tested against pathogens from community-acquired respiratory tract infections, including those with elevated or resistant-level fluoroquinolone MIC values. Diagn Microbiol Infect Dis 2007; 58: 9-17.
25. Brown SD, Rybak MJ. Antimicrobial susceptibility of Streptococcus pneumoniaeStreptococcus pyogenes and Haemophilus influenzaecollected from patients across the USA, in 2001-2002, as part of the PROTEKT US study. J Antimicrob Chemother 2004; 54 (Suppl 1): i7-15.
26. Doern GV, Brown SD. Antimicrobial susceptibility among community-acquired respiratory tract pathogens in the USA: data from PROTEKT US 2000-01. J Infect 2004; 48: 56-65.
27. Hoban D, Waites K, Felmingham D. Antimicrobial susceptibility of community-acquired respiratory tract pathogens in North America in 1999-2000: findings of the PROTEKT surveillance study. Diagn Microbiol Infect Dis 2003; 45: 251-9.
28. Jacobs MR, Felmingham D, Appelbaum PC, Gruneberg RN; The Alexander Project Group. The Alexander Project 1998-2000: susceptibility of pathogens isolated from community-acquired respiratory tract infection to commonly used antimicrobial agents. J Antimicrob Chemother 2003; 52: 229-46.
29. Karlowsky JA, Thornsberry C, Jones ME, Evangelista AT, Critchley IA, Sahm DF; TRUST Surveillance Program. Factors associated with relative rates of antimicrobial resistance among Streptococcus pneumoniae in the United States: results from the TRUST Surveillance Program (1998-2002). Clin Infect Dis 2003; 36: 963-70.
30. Sahm DF, Weaver MK, Flamm RK, et al. Rates of antimicrobial resistance among clinical isolates of Streptococcus pneumoniae in the United States: results from the TRUST 7 (2002-2003) surveillance study [abstract No. 201 plus poster]. 41st Annual Meeting of the Infectious Diseases Society of America; October 9-12, 2003; San Diego, California.
31. Davidson RJ, Melano R, Forward KR; Canadian Invasive Pneumococcal Disease Surveillance Group. Antimicrobial resistance among invasive isolates of Streptococcus pneumoniae collected across Canada. Diagn Microbiol Infect Dis 2007; 59: 75-80.
32. Anderson VR, Perry CM. Levofloxacin: a review of its use as a high-dose, short-course treatment for bacterial infection. Drugs 2008; 68: 535-65.
33. Bouchillon S, Hackel M, Johnson J, Pace J. The carbapenem PZ-601 (SMP-601) has potent in vitro Gram-positive, Gram-negative and anaerobic bacterial activity [poster No. F1-343]. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 2007; Chicago, Illinois.
34. Hansen GT, Blondeau JM. Comparison of the minimum inhibitory, mutant prevention and minimum bactericidal concentrations of ciprofloxacin, levofloxacin and garenoxacin against enteric Gram-negative urinary tract infection pathogens. J Chemother 2005; 17: 484-92.
35. Zhanel GG, Hisanaga TL, Laing NM, DeCorby MR, Nichol KA, Weshnoweski B, Johnson J, Noreddin A, Low DE, Karlowsky JA, for the NAUTICA Group, Hoban DJ. Antibiotic resistance in Escherichia coli outpatient urinary isolates: final results from the North American Urinary Tract Infection Collaborative Alliance (NAUTICA). Int J Antimicrob Agents 2006; 27: 468-75.
36. Thornsberry C, Sahm DF, Kelly LJ, Critchley IA, Jones ME, Evangelista AT, Karlowsky JA. Regional trends in antimicrobial resistance among clinical isolates of Streptococcus pneumoniaeHaemophilus influenzae, and Moraxella catarrhalis in the United States: results from the TRUST Surveillance Program, 1999-2000. Clin Infect Dis 2002; 34 (Suppl 1): S4-16.
37. Karlowsky JA, Thornsberry C, Critchley IA, Jones ME, Evangelista AT, Noel GJ, Sahm DF. Susceptibilities to levofloxacin in Streptococcus pneumoniaeHaemophilus influenzae, and Moraxella catarrhalis clinical isolates from children: results from 2000-2001 and 2001-2002 TRUST studies in the United States. Antimicrob Agents Chemother 2003; 47: 1790-7.
38. Soriano F, Granizo JJ, Coronel P, Gimeno M, Rodenas E, Gracia M, Garcia C, Fernandez-Roblas R, Esteban J, Gadea I. Antimicrobial susceptibility of Haemophilus influenzaeHaemophilus parainfluenzaeand Moraxella catarrhalis isolated from adult patients with respiratory tract infections in four southern European countries. The ARISE project. Int J Antimicrob Agents 2004; 23: 296-9.
39. Zhanel GG, Walters M, Laing N, Hoban DJ. In vitropharmacodynamic modelling simulating free serum concentrations of fluoroquinolones against multidrug-resistant Streptococcus pneumoniae. J Antimicrob Chemother 2001; 47: 435-40.
40. Klepser ME, Ernst EJ, Petzold CR, Rhomberg P, Doern GV. Comparative bactericidal activities of ciprofloxacin, clinafloxacin, grepafloxacin, levofloxacin, moxifloxacin, and trovafloxacin against Streptococcus pneumoniae in a dynamic in vitro model. Antimicrob Agents Chemother 2001; 45: 673-8.
41. Cipro(R) (ciprofloxacin) [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc., October 2008.
42. Karlowsky JA, Jones ME, Mayfield DC, Thornsberry C, Sahm DF. Ceftriaxone activity against Gram-positive and Gram-negative pathogens isolated in US clinical microbiology laboratories from 1996 to 2000: results from The Surveillance Network (TSN) Database-USA. Int J Antimicrob Agents 2002; 19: 413-26.
43. Milatovic D, Schmitz FJ, Brisse S, Verhoef J, Fluit AC. In vitroactivities of sitafloxacin (DU-6859a) and six other fluoroquinolones against 8,796 clinical bacterial isolates. Antimicrob Agents Chemother 2000; 44: 1102-7.
44. Thornsberry C, Karlowsky JA, Weaver MK, et al. Current view of antimicrobial susceptibility among common Gram-negative 2003 TRUST surveillance data [abstract No. 222 plus poster]. 41st Annual Meeting of Infectious Diseases Society of America; October 9-12, 2003; San Diego, California.
45. Evangelista AT, Yee YC, Brown NP, Crites E, Sahm DF, Cohen MA, Thornsberry C. Discordant levofloxacin (LV) and ciprofloxacin (CP) susceptibility profiles among common Gram-negative bacilli; indication of potential differences in mode of action? [poster No. D-711] 46th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 2006; San Francisco, California.
46. Karlowsky JA, Jones ME, Thornsberry C, Evangelista AT, Yee YC, Sahm DF. Stable antimicrobial susceptibility rates for clinical isolates of Pseudomonas aeruginosa from the 2001-2003 tracking resistance in the United States today surveillance studies. Clin Infect Dis 2005; 40 (Suppl 2): S89-98.
47. Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis 2007; 44 (Suppl 2): S27-72.
48. Noel GJ, Goodman DB, Chien S, Solanki B, Padmanabhan M, Natarajan J. Measuring the effects of supratherapeutic doses of levofloxacin on healthy volunteers using four methods of QT correction and periodic and continuous ECG recordings. J Clin Pharmacol 2004; 44: 464-73.
49. Data from study LOFBO-PHI 108. RW Johnson/Ortho-McNeil Pharmaceutical, Inc. (data on file).
50. Dunbar LM, Wunderink RG, Habib MP, Smith LG, Tennenberg AM, Khashab MM, Wiesinger BA, Xiang JX, Zadeikis N, Kahn JB. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis 2003; 37: 752-60.
51. Bochud PY, Moser F, Erard P, Verdon F, Studer JP, Villard G, Cosendai A, Cotting M, Heim F, Tissot J, Strub Y, Pazeller M, Saghafi L, Wenger A, Germann D, Matter L, Bille J, Pfister L, Francioli P. Community-acquired pneumonia. A prospective outpatient study. Medicine (Baltimore) 2001; 80: 75-87.
52. Falguera M, Sacristan O, Nogues A, Ruiz-Gonzalez A, Garcia M, Manonelles A, Rubio-Caballero M. Nonsevere community-acquired pneumonia: correlation between cause and severity or comorbidity. Arch Intern Med 2001; 161: 1866-72.
53. Dunbar LM, Jubelin BC, Sibley D. Co-existence of pathogens in community-acquired pneumonia (CAP). 40th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 2000; Toronto, Canada.
54. Dunbar LM, Khashab MM, Kahn JB, Zadeikis N, Xiang JX, Tennenberg AM. Efficacy of 750-mg, 5-day levofloxacin in the treatment of community-acquired pneumonia caused by atypical pathogens. Curr Med Res Opin 2004; 20: 555-63.
55. Ortho-McNeil Pharmaceutical, Inc. (data on file).
56. Mandell LA, Bartlett JG, Dowell SF, File TM Jr, Musher DM, Whitney C; Infectious Diseases Society of America. Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis 2003; 37: 1405-33.
57. Bartlett JG, Dowell SF, Mandell LA, File TM Jr, Musher DM, Fine MJ. Guidelines from the Infectious Diseases Society of America: practice guidelines for the management of community-acquired pneumonia in adults. Clin Infect Dis 2000; 31: 347-82.
58. Frazee BW. J Respir Dis 2004, 25: 37-44.
59. Ambrose PG, Anon JB, Bhavnani SM, Okusanya OO, Jones RN, Paglia MR, Kahn J, Drusano GL. Use of pharmacodynamic endpoints for the evaluation of levofloxacin for the treatment of acute maxillary sinusitis. Diagn Microbiol Infect Dis 2008; 61: 13-20.
60. Anzueto A, Niederman MS, Pearle J, Restrepo MI, Heyder A, Choudhri SH; Community-Acquired Pneumonia Recovery in the Elderly Study Group. Community-Acquired Pneumonia Recovery in the Elderly (CAPRIE): efficacy and safety of moxifloxacin therapy versus that of levofloxacin therapy. Clin Infect Dis 2006; 42: 73-81.
61. Shorr AF, Zadeikis N, Xiang JX, Tennenberg AM, Wes Ely E. A multicenter, randomized, double-blind, retrospective comparison of 5- and 10-day regimens of levofloxacin in a subgroup of patients aged ≥ 65 years with community-acquired pneumonia. Clin Ther 2005; 27: 1251-9.
62. Kahn JB, Bahal N, Wiesinger BA, Xiang J. Cumulative clinical trial experience with levofloxacin for patients with community-acquired pneumonia – associated pneumococcal bacteremia. Clin Infect Dis 2004; 38 (Suppl 1): S34-42.
63. Cravit(R) (levofloxacin tablets, injection) [package insert]. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc., 2004.
64. Ortho-McNeil Pharmaceutical, Inc. (data on file, CAPSS-232).
65. Rubinstein E, Camm J. Cardiotoxicity of fluoroquinolones. J Antimicrob Chemother 2002; 49: 593-6.
66. Data from study LOFBO-PHI-112. RW Johnson/Ortho-McNeil Pharmaceutical, Inc. (data on file).
67. FDA Federal Register 2008 September 9; 73: 175. Available from: URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20938.pdf. Accessed October 2008.
68. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing. Eighteenth informational Supplement. M100-S18, Wayne, PA: CLSI Document, 2008.
69. Ortho-McNeil-Janssen Pharmaceuticals, Inc. (data on file).
70. Polk R. Optimal use of modern antibiotics: emerging trends. Clin Infect Dis 1999; 29: 264-74.
71. World Health Organization. WHO Global Strategy for Containment of Antimicrobial Resistance. WHO/CDS/CSR/DRS/2001.2. Available from: URL: http://whqlibdoc.who.int/hq/2001/WHO_CDS_CSR_DRS_2001.2.pdf.
72. Smith HJ, Walters M, Hisanaga T, Zhanel GG, Hoban DJ. Mutant prevention concentrations for single-step fluoroquinolone-resistant mutants of wild-type, efflux-positive, or parC or GyrA mutation-containing Streptococcus pneumoniae isolates. Antimicrob Agents Chemother 2004; 48: 3954-8.
73. Stein GE, Schooley SL, Nicolau DP. Urinary bactericidal activity of single doses (250, 500, 750 and 1000 mg) of levofloxacin against fluoroquinolone-resistant strains of Escherichia coli. Int J Antimicrob Agents 2008; 32: 320-5.
74. Data from TRUST surveillance study. Ortho-McNeil Pharmaceutical, Inc. (data on file).
75. Ortho-McNeil Pharmaceutical, Inc. (Utilization data on file).
76. Segreti J, House HR, Siegel RE. Principles of antibiotic treatment of community-acquired pneumonia in the outpatient setting. Am J Med 2005; 118 (Suppl 7A): 21S-28S.
77. Adam HJ, Schurek KN, Nichol KA, Hoban CJ, Baudry TJ, Laing NM, Hoban DJ, Zhanel GG. Molecular characterization of increasing fluoroquinolone resistance in Streptococcus pneumoniae isolates in Canada, 1997 to 2005. Antimicrob Agents Chemother 2007; 51: 198-207.
78. Schafer J, Hovde LB, Simonson D, Rotschafer JC. In vitropharmacodynamics of moxifloxacin versus levofloxacin against 4 strains of Streptococcus pneumoniae: 1 wild type, 2 first-step parCmutants, and 1 pump mutant. Diagn Microbiol Infect Dis 2008; 60: 155-61.
79. Louie A, Brown DL, Liu W, Kulawy RW, Deziel MR, Drusano GL. In vitro infection model characterizing the effect of efflux pump inhibition on prevention of resistance to levofloxacin and ciprofloxacin in Streptococcus pneumoniae. Antimicrob Agents Chemother 2007; 51: 3988-4000.