Journal of Antimicrobial Chemotherapy (1999) 43, Suppl. A, 117-128
© 1999 The British Society for Antimicrobial Chemotherapy
Intravenous and oral mono- or combination-therapy in the treatment of severe infections: ciprofloxacin versus standard antibiotic therapy
a Reno Veterans Medical Center, Reno, NV; b Yale University School of Medicine, New Haven, CT; c Via Christi Regional Medical Center, Wichita, KS; d University of Louisville, Louisville, KY; e Bayer Corporation, Pharmaceutical Division, West Haven, CT, USA
Five hundred and forty patients with severe infection were enrolled in a multicentre, prospective,
randomized, non-blinded study to compare the efficacy and safety of iv ciprofloxacin with iv
standard therapy. Five hundred and thirty-one patients received at least one dose of study drug for
pneumonia (310), septicaemia (112) or skin and skin structure infection (109). Intravenous
ciprofloxacin (400 mg, every 8 h) or iv ciprofloxacin (400 mg, every 8 h) plus a ß-lactam
were compared with a standard monotherapy (ß-lactam) or combination
(aminoglycoside plus a ß-lactam) therapy. Patients were treated parenterally for a
minimum of 2 or 3 days, then at the discretion of the investigator could be switched to oral
therapy (ciprofloxacin 750 mg, every 12 h or a standard oral therapy). Patients were randomized
in the ratio of 2:1 for the ciprofloxacin and standard therapy treatment groups and stratified to
monotherapy if the APACHE II score was 
20 or to combination therapy if the APACHE
II score was 21- 29.
Three hundred and ninety-five (74%) patients were valid for the efficacy analysis: these
comprised 242 pneumonia (167 ciprofloxacin and 75 standard therapy), 70 septicaemia (47
ciprofloxacin and 23 standard therapy), and 83 skin infections (56 ciprofloxacin and 27
standard). The primary efficacy variable was clinical response and the secondary efficacy
assessment was bacteriological response at the end of therapy (2 or 3 days after treatment). The
mean duration of therapy for patients receiving only iv monotherapy or combination therapy was
shorter (9- 10 days) than for patients receiving sequential iv/po therapy (14- 17 days). At the end
of therapy, overall clinical resolution/improvement (success) for monotherapy was 138/166
(83%) for the ciprofloxacin group, compared with 74/87 (85%) for standard-treated patients
(95% CI =-11.5% to 7.6%), and for combination therapy the response was 43/51
(84%) for the ciprofloxacin group and 14/20 (70%) for standard-treated patients (95% CI
=-6.3% to 34.9%). For pneumonia, the most frequent infection treated, clinical
success rates following monotherapy were 85% for ciprofloxacin and 83% for standard-treated
patients and 83% for ciprofloxacin compared with 69% for standard-treated patients in the
combination therapy group. Bacteriological eradication/presumed eradication following
monotherapy was 85/102 (83%) for ciprofloxacin and 31/46 (67%) for standard-treated patients
(95% CI = 1.6% to 30.3%), and that for combination therapy was 29/36 (81%) for
ciprofloxacin and 7/10 (70%) for standard-treated patients (95% CI =-18.3% to
39.5%). Drug-related adverse events, primarily diarrhoea and nausea, were reported in 22% of
ciprofloxacin-treated patients and 20% of standard-treated patients. In summary, ciprofloxacin
administered alone or in combination was found to be effective in treating a wide range of severe
infections.
* Corresponding address. Reno Veterans Medical Center, 1000 Locust Street, Reno, NV 89500, USA. Tel: +1-702-786-7200; Fax: +1-702-328-1769; E-mail JandP{at}smilen.reno.nv.us
Current address. Bristol-Myers Squibb, Wallingford, CT,
USA.
See acknowledgement section.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  M. E. Falagas, D. K. Matthaiou, and K. Z. Vardakas Fluoroquinolones vs {beta}-Lactams for Empirical Treatment of Immunocompetent Patients With Skin and Soft Tissue Infections: A Meta-analysis of Randomized Controlled Trials Mayo Clin. Proc., December 1, 2006; 81(12): 1553 - 1566. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Mizunaga, T. Kamiyama, Y. Fukuda, M. Takahata, and J. Mitsuyama Influence of inoculum size of Staphylococcus aureus and Pseudomonas aeruginosa on in vitro activities and in vivo efficacy of fluoroquinolones and carbapenems J. Antimicrob. Chemother., July 1, 2005; 56(1): 91 - 96. [Abstract] [Full Text] [PDF]
|
|