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Journal of Antimicrobial Chemotherapy (1999) 43, 529-539
© 1999 The British Society for Antimicrobial Chemotherapy

Levofloxacin versus cefuroxime axetil in the treatment of acute exacerbation of chronic bronchitis: results of a randomized, double-blind study

P. M. Shaha,*, F. P. V. Maesenb, A. Dolmannc, N. Vetterd, E. Fisse and R. Weschf

a Klinikum der Johann Wolfgang Goethe-Universitaet, Zentrum der Inneren Medizin, Medizinische Klinik III, Schwerpunkt Infektiologie, D-60590 Frankfurt, Germany b De Wever Ziekenhuis, Department of Pneumology, Henri-Dunant 5, NL-6401 CX Heerlen, The Netherlands c Hospital Antonio Cetrangolo, Italia 1750, RA-1602 Florida, Buenos Aires, Argentina d Pulmonologisches Zentrum der Stadt Wien, Sanatoriumstraat 2, A-1145, Vienna, Austria e Hospital Oswaldo Cruz, Departamento de Pneumologia, Rua Joao Juliao 331, BR-01323-903, São Paulo, Brazil f Hoechst Marion Roussel, D-65926, Frankfurt, Germany

A randomized, double-blind, double-dummy, three-arm parallel design, multicentre study was conducted among adult patients with acute exacerbation of chronic bronchitis (AECB) in order to compare the efficacy and safety of two different doses of levofloxacin with cefuroxime axetil. A total of 832 patients were randomized to receive oral levofloxacin (250 mg od or 500 mg od) or oral cefuroxime axetil (250 mg bd) for 7- 10 days. The primary efficacy analysis was based on the clinical response in patients with bacteriologically confirmed AECB, determined 5- 14 days after the end of therapy (per-protocol population). Of 839 patients enrolled (at 71 centres in 14 countries), seven were not treated, giving an intention-to-treat (ITT) population of 832. In total, 281 patients received levofloxacin 250 mg, 280 received levofloxacin 500 mg and 271 received cefuroxime axetil. The cure rates in the ITT population were: levofloxacin 250 mg, 70% (196/281); levofloxacin 500 mg, 70% (195/280); cefuroxime axetil, 61% (166/271); those in the per-protocol population were: 78% (121/156), 79% (108/137) and 66% (88/134), respectively. Both doses of levofloxacin were at least as effective as cefuroxime axetil and were active against the main pathogens of clinical relevance (Haemophilus influenzae, Streptococcus pneumoniae and Moraxella catarrhalis). All three treatment regimens were equally well tolerated. In conclusion, the results show that levofloxacin (250 mg and 500 mg) od is effective and well tolerated in the treatment of AECB in adult patients.

* Corresponding author. Tel: +49-69-6301-6614; Fax: +49-69-6301-7717; E-mail: shah{at}em.uni-frankfurt.de


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