Clinical and bacteriological outcomes in hospitalised patients with community-acquired pneumonia treated with azithromycin plus ceftriaxone, or ceftriaxone plus clarithromycin or erythromycin: a prospective, randomised, multicentre study

Authors: Tamm, M.¹; Todisco, T.²; Feldman, C.³; Garbino, J.⁴; Blasi, F.⁵; Hogan, P.⁶; de Caprariis, P. J.⁶; Hoepelman, I. M.⁷

Source: Clinical Microbiology & Infection, Volume 13, Number 2, February 2007 , pp. 162-171(10)

Publisher: Wiley-Blackwell

Abstract:

This study compared patients with moderate-to-severe community-acquired pneumonia (CAP) requiring hospitalisation, who received initial therapy with either intravenous ceftriaxone plus intravenous azithromycin, followed by step-down to oral azithromycin (n = 135), with patients who received intravenous ceftriaxone combined with either intravenous clarithromycin or erythromycin, followed by step-down to either oral clarithromycin or erythromycin (n = 143). Clinical and bacteriological outcomes were evaluated at the end of therapy (EOT; day 12-16) or at the end of study (EOS; day 28-35). At baseline, mean APACHE II scores were 13.3 and 12.6, respectively, with >50% of patients classified as Fine Pneumonia Severity Index (PSI) category IV or V. Clinical success rates (cure or improvement) in the modified intent-to-treat (MITT) population at EOT were 84.3% in the ceftriaxone/azithromycin group and 82.7% in the ceftriaxone/clarithromycin or erythromycin group. At EOS, MITT success rates (cure only) were 81.7% and 75.0%, respectively. Equivalent success rates in the clinically evaluable population were 83% and 87%, respectively, at EOT, and 79% and 78%, respectively, at EOS. MITT bacteriological eradication rates were 73.2% and 67.4%, respectively, at EOT, and 68.3% vs. 60.9%, respectively, at EOS. Mean length of hospital stay (LOS) was 10.7 and 12.6 days, and the mean duration of therapy was 9.5 and 10.5 days, respectively. The incidence of infusion-related adverse events was 16.3% and 25.2% (p 0.04), respectively. An intravenous-to-oral regimen of ceftriaxone/azithromycin was at least equivalent in efficacy and safety to the comparator regimen and appeared to be a suitable treatment option for hospitalised patients with CAP.

Keywords: Azithromycin; ceftriaxone; clarithromycin; community-acquired pneumonia; erythromycin; therapy

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1469-0691.2006.01633.x

Affiliations: 1: Division of Pneumology, University Hospital Basel, Basel, Switzerland 2: Pulmonary Division and Respiratory ICU, Silvestrini Hospital, Perugia, Italy 3: Division of Pulmonology, Department of Medicine, Johannesburg Hospital and University of the Witwatersrand, Johannesburg, South Africa 4: Infectious Diseases Division, University Hospital, Geneva, Switzerland 5: University of Milan, IRCCS, Policlinico, Milan, Italy 6: Pfizer, New York, NY, USA 7: Department of Internal Medicine and Infectious Diseases, University Medical Centre, Utrecht, The Netherlands

Publication date: 2007-02-01

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