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.
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.
Tamm
M
M
Division of Pneumology, University Hospital Basel, Basel, Switzerland. Electronic address: MTamm@uhbs.ch.
Todisco
T
T
Pulmonary Division and Respiratory ICU, Silvestrini Hospital, Perugia, Italy.
Feldman
C
C
Division of Pulmonology, Department of Medicine, Johannesburg Hospital and University of the Witwatersrand, Johannesburg, South Africa.
Garbino
J
J
Infectious Diseases Division, University Hospital, Geneva, Switzerland.
Blasi
F
F
University of Milan, IRCCS, Policlinico, Milan, Italy.
Hogan
P
P
Pfizer, New York, NY, USA.
de Caprariis
P J
PJ
Pfizer, New York, NY, USA.
Hoepelman
I M
IM
Department of Internal Medicine and Infectious Diseases, University Medical Centre, Utrecht, The Netherlands.
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D004917:Erythromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006760:Hospitalization; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D011897:Random Allocation; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004917:Erythromycin; D002443:Ceftriaxone; D017963:Azithromycin; D017291:Clarithromycin