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. 1997 Sep;41(9):1965–1972. doi: 10.1128/aac.41.9.1965

A multicenter, randomized study comparing the efficacy and safety of intravenous and/or oral levofloxacin versus ceftriaxone and/or cefuroxime axetil in treatment of adults with community-acquired pneumonia.

T M File Jr 1, J Segreti 1, L Dunbar 1, R Player 1, R Kohler 1, R R Williams 1, C Kojak 1, A Rubin 1
PMCID: PMC164046  PMID: 9303395

Abstract

Five hundred ninety patients were enrolled in a prospective, multicenter, randomized trial comparing the efficacy and safety of 7 to 14 days of levofloxacin treatment with that of ceftriaxone and/or cefuroxime axetil in the management of community-acquired pneumonia in adults. Patients received either intravenous and/or oral levofloxacin (500 mg once daily) or the comparative agents, parenteral ceftriaxone (1 to 2 g once to twice daily) and/or oral cefuroxime axetil (500 mg twice daily). Erythromycin or doxycycline could be added to the comparator arm at the investigator's discretion. The decision to use an intravenous or oral antimicrobial agent for initial therapy was made by the investigator. Clinical and microbiological evaluations were completed at the baseline, during treatment, 5 to 7 days posttherapy, and 3 to 4 weeks posttherapy. Four hundred fifty-six patients (226 given levofloxacin and 230 administered ceftriaxone and/or cefuroxime axetil) were evaluable for clinical efficacy. Streptococcus pneumoniae and Haemophilus influenzae were isolated in 15 and 12%, respectively, of clinically evaluable patients. One hundred fifty atypical pathogens were identified: 101 were Chlamydia pneumoniae, 41 were Mycoplasma pneumoniae, and 8 were Legionella pneumophila. Clinical success at 5 to 7 days posttherapy was superior for the levofloxacin group (96%) compared with the ceftriaxone and/or cefuroxime axetil group (90%) (95% confidence interval [CI] of -10.7 to -1.3). Among patients with typical respiratory pathogens who were evaluable for microbiological efficacy, the overall bacteriologic eradication rates were superior for levofloxacin (98%) compared with the ceftriaxone and/or cefuroxime axetil group (85%) (95% CI of -21.6 to -4.8). Levofloxacin eradicated 100% of the most frequently reported respiratory pathogens (i.e., H. influenzae and S. pneumoniae) and provided a >98% clinical success rate in patients with atypical pathogens. Both levofloxacin and ceftriaxone-cefuroxime axetil eradicated 100% of the S. pneumoniae cells detected in blood culture. Drug-related adverse events were reported in 5.8% of patients receiving levofloxacin and in 8.5% of patients administered ceftriaxone and/or cefuroxime axetil. Gastrointestinal and central and peripheral nervous system adverse events were the most common events reported in each treatment group. In conclusion, these results demonstrate that treatment with levofloxacin is superior to ceftriaxone and/or cefuroxime axetil therapy in the management of community-acquired pneumonia in adults.

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Selected References

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  1. Abbate G. F., Alagia I., Giaquinto E., Leonessa V., Savioli L., Altucci P., Caputi M., Guarino C., Micillo E., Catena E. Treatment of lower respiratory tract infections with ceftriaxone and cefotaxime. A comparative study. Respiration. 1986;49(3):222–230. doi: 10.1159/000194882. [DOI] [PubMed] [Google Scholar]
  2. Bartlett J. G., Mundy L. M. Community-acquired pneumonia. N Engl J Med. 1995 Dec 14;333(24):1618–1624. doi: 10.1056/NEJM199512143332408. [DOI] [PubMed] [Google Scholar]
  3. Bittner M. J., Pugsley M. P., Horowitz E. A., Strike D. G., Sanders C. C., Preheim L. C. Randomised comparison of ceftriaxone and cefamandole therapy in lower respiratory tract infections in an elderly population. J Antimicrob Chemother. 1986 Nov;18(5):621–627. doi: 10.1093/jac/18.5.621. [DOI] [PubMed] [Google Scholar]
  4. Cooper T. J., Ladusans E., Williams P. E., Polychronopoulos V., Gaya H., Rudd R. M. A comparison of oral cefuroxime axetil and oral amoxycillin in lower respiratory tract infections. J Antimicrob Chemother. 1985 Sep;16(3):373–378. doi: 10.1093/jac/16.3.373. [DOI] [PubMed] [Google Scholar]
  5. Fang G. D., Fine M., Orloff J., Arisumi D., Yu V. L., Kapoor W., Grayston J. T., Wang S. P., Kohler R., Muder R. R. New and emerging etiologies for community-acquired pneumonia with implications for therapy. A prospective multicenter study of 359 cases. Medicine (Baltimore) 1990 Sep;69(5):307–316. doi: 10.1097/00005792-199009000-00004. [DOI] [PubMed] [Google Scholar]
  6. Fass R. J. Aetiology and treatment of community-acquired pneumonia in adults: an historical perspective. J Antimicrob Chemother. 1993 Jul;32 (Suppl A):17–27. doi: 10.1093/jac/32.suppl_a.17. [DOI] [PubMed] [Google Scholar]
  7. Fu K. P., Lafredo S. C., Foleno B., Isaacson D. M., Barrett J. F., Tobia A. J., Rosenthale M. E. In vitro and in vivo antibacterial activities of levofloxacin (l-ofloxacin), an optically active ofloxacin. Antimicrob Agents Chemother. 1992 Apr;36(4):860–866. doi: 10.1128/aac.36.4.860. [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Fujimoto T., Mitsuhashi S. In vitro antibacterial activity of DR-3355, the S-(-)-isomer of ofloxacin. Chemotherapy. 1990;36(4):268–276. doi: 10.1159/000238777. [DOI] [PubMed] [Google Scholar]
  9. Grasela T. H., Jr, Paladino J. A., Schentag J. J., Huepenbecker D., Rybacki J., Purcell J. B., Fiedler J. B. Clinical and economic impact of oral ciprofloxacin as follow-up to parenteral antibiotics. DICP. 1991 Jul-Aug;25(7-8):857–862. doi: 10.1177/106002809102500724. [DOI] [PubMed] [Google Scholar]
  10. Grassi C., Mangiarotti P. International experiences with ceftriaxone in the treatment of lower respiratory tract infections. Chemioterapia. 1987 Oct;6(5):364–373. [PubMed] [Google Scholar]
  11. Grayston J. T., Diwan V. K., Cooney M., Wang S. P. Community- and hospital-acquired pneumonia associated with Chlamydia TWAR infection demonstrated serologically. Arch Intern Med. 1989 Jan;149(1):169–173. [PubMed] [Google Scholar]
  12. Hammerschlag M. R., Qumei K. K., Roblin P. M. In vitro activities of azithromycin, clarithromycin, L-ofloxacin, and other antibiotics against Chlamydia pneumoniae. Antimicrob Agents Chemother. 1992 Jul;36(7):1573–1574. doi: 10.1128/aac.36.7.1573. [DOI] [PMC free article] [PubMed] [Google Scholar]
  13. Hardy D. J., Hensey D. M., Beyer J. M., Vojtko C., McDonald E. J., Fernandes P. B. Comparative in vitro activities of new 14-, 15-, and 16-membered macrolides. Antimicrob Agents Chemother. 1988 Nov;32(11):1710–1719. doi: 10.1128/aac.32.11.1710. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Kauppinen M. T., Saikku P., Kujala P., Herva E., Syrjälä H. Clinical picture of community-acquired Chlamydia pneumoniae pneumonia requiring hospital treatment: a comparison between chlamydial and pneumococcal pneumonia. Thorax. 1996 Feb;51(2):185–189. doi: 10.1136/thx.51.2.185. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Kleemola S. R., Karjalainen J. E., Räty R. K. Rapid diagnosis of Mycoplasma pneumoniae infection: clinical evaluation of a commercial probe test. J Infect Dis. 1990 Jul;162(1):70–75. doi: 10.1093/infdis/162.1.70. [DOI] [PubMed] [Google Scholar]
  16. Kuo C. C., Jackson L. A., Campbell L. A., Grayston J. T. Chlamydia pneumoniae (TWAR). Clin Microbiol Rev. 1995 Oct;8(4):451–461. doi: 10.1128/cmr.8.4.451. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Lee B. L., Padula A. M., Kimbrough R. C., Jones S. R., Chaisson R. E., Mills J., Sande M. A. Infectious complications with respiratory pathogens despite ciprofloxacin therapy. N Engl J Med. 1991 Aug 15;325(7):520–521. doi: 10.1056/nejm199108153250719. [DOI] [PubMed] [Google Scholar]
  18. Marrie T. J., Grayston J. T., Wang S. P., Kuo C. C. Pneumonia associated with the TWAR strain of Chlamydia. Ann Intern Med. 1987 Apr;106(4):507–511. doi: 10.7326/0003-4819-106-4-507. [DOI] [PubMed] [Google Scholar]
  19. Neu H. C., Fu K. P. Cefuroxime, a beta-lactamase-resistant cephalosporin with a broad spectrum of gram-positive and -negative activity. Antimicrob Agents Chemother. 1978 Apr;13(4):657–664. doi: 10.1128/aac.13.4.657. [DOI] [PMC free article] [PubMed] [Google Scholar]
  20. Paladino J. A., Sperry H. E., Backes J. M., Gelber J. A., Serrianne D. J., Cumbo T. J., Schentag J. J. Clinical and economic evaluation of oral ciprofloxacin after an abbreviated course of intravenous antibiotics. Am J Med. 1991 Nov;91(5):462–470. doi: 10.1016/0002-9343(91)90181-v. [DOI] [PubMed] [Google Scholar]
  21. Plouffe J. F., Herbert M. T., File T. M., Jr, Baird I., Parsons J. N., Kahn J. B., Rielly-Gauvin K. T. Ofloxacin versus standard therapy in treatment of community-acquired pneumonia requiring hospitalization. Pneumonia Study Group. Antimicrob Agents Chemother. 1996 May;40(5):1175–1179. doi: 10.1128/aac.40.5.1175. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Potgieter P. D., Linton D. M., Forder A. A., Plumb H. Ceftriaxone therapy in adults with severe lower respiratory tract infections. S Afr Med J. 1986 Apr 12;69(8):495–497. [PubMed] [Google Scholar]
  23. Richards D. M., Heel R. C., Brogden R. N., Speight T. M., Avery G. S. Ceftriaxone. A review of its antibacterial activity, pharmacological properties and therapeutic use. Drugs. 1984 Jun;27(6):469–527. doi: 10.2165/00003495-198427060-00001. [DOI] [PubMed] [Google Scholar]
  24. Schleupner C. J., Anthony W. C., Tan J., File T. M., Lifland P., Craig W., Vogelman B. Blinded comparison of cefuroxime to cefaclor for lower respiratory tract infections. Arch Intern Med. 1988 Feb;148(2):343–348. [PubMed] [Google Scholar]
  25. Une T., Fujimoto T., Sato K., Osada Y. In vitro activity of DR-3355, an optically active ofloxacin. Antimicrob Agents Chemother. 1988 Sep;32(9):1336–1340. doi: 10.1128/aac.32.9.1336. [DOI] [PMC free article] [PubMed] [Google Scholar]

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