A prospective, randomized, double-blind multicenter comparison of parenteral ertapenem and ceftriaxone for the treatment of hospitalized adults with community-acquired pneumonia

Clinical Trial

Norbert Vetter et al. Clin Ther. 2002 Nov.

Abstract

Background: Ertapenem is a once-daily parenteral beta-lactam licensed in the United States in November 2001 and in Europe in May 2002.

Objective: This study compared the efficacy and safety profiles of ertapenem with those of ceftriaxone for the treatment of hospitalized adult patients with serious community-acquired pneumonia (CAP) requiring parenteral therapy.

Methods: In this prospective, double-blind (with sponsor blinding), multicenter study, adult patients with CAP were stratified by Pneumonia Severity Index (< or = 3 or > 3) and age (< or = 65 or > 65 years) and randomized (2:1) to receive IV or intramuscular (IM) ertapenem 1 g once daily or IV or IM ceftriaxone 1 g once daily. Investigators could switch patients to an oral antimicrobial agent if clinical improvement was shown after at least 3 days of parenteral therapy.

Results: A total of 364 patients were randomized to treatment: 239 to the ertapenem group and 125 to the ceftriaxone group. Three patients in the ertapenem group and 2 in the ceftriaxone group did not receive study therapy. Of the treated patients, 77.1% (182/236) of patients in the ertapenem group and 75.6% (93/123) in the ceftriaxone group were clinically evaluable. Among clinically evaluable patients, the mean (SD) durations of parenteral and total (parenteral plus optional oral) therapy were 5.5 (2.6) and 11.5 (2.7) days for ertapenem and 5.6 (2.8) and 11.7 (3.0) days for ceftriaxone, respectively. Streptococcus pneumoniae was the most frequently isolated pathogen in both treatment groups. Cure rates were 92.2% for clinically evaluable patients in the ertapenem group and 93.6% for those in the ceftriaxone group (95% CI for the difference, adjusted for stratum, -8.6 to 5.7), fulfilling the criteria for statistical equivalence. At completion of parenteral therapy, 94.7% of patients in the ertapenem group and 95.8% in the ceftriaxone group showed clinical improvement. Infused vein complications (ertapenem, 3.4% [8/236]; ceftriaxone, 7.3% [9/123]) and elevated transaminase levels (ertapenem, 6.3% [13/207]; ceftriaxone, 7.1% [8/113]) were the most common adverse events in both groups.

Conclusions: In this study of hospitalized adult patients, ertapenem therapy, with an oral switch option, was as effective as ceftriaxone with the same oral switch option for treatment of CAP requiring initial parenteral therapy. The overall safety profiles of the 2 drugs were comparable.

PubMed Disclaimer

Cited by

Preclinical Pharmacokinetic/Pharmacodynamic Studies and Clinical Trials in the Drug Development Process of EMA-Approved Antibacterial Agents: A Review.
Jorda A, Zeitlinger M. Jorda A, et al. Clin Pharmacokinet. 2020 Sep;59(9):1071-1084. doi: 10.1007/s40262-020-00892-0. Clin Pharmacokinet. 2020. PMID: 32356105 Free PMC article. Review.
Risk factors associated with the development of seizures among adult patients treated with ertapenem: A matched case-control study.
Lee YC, Huang YJ, Hung MC, Hung SC, Hsiao CY, Cho HL, Lai LF, Tong SH, Wang JT. Lee YC, et al. PLoS One. 2017 Jul 31;12(7):e0182046. doi: 10.1371/journal.pone.0182046. eCollection 2017. PLoS One. 2017. PMID: 28759588 Free PMC article.
Antibiotic expected effectiveness and cost under real life microbiology: evaluation of ertapenem and ceftriaxone in the treatment of community-acquired pneumonia for elderly patients in Spain.
Grau S, Lozano V, Valladares A, Cavanillas R, Xie Y, Nocea G. Grau S, et al. Clinicoecon Outcomes Res. 2014 Feb 13;6:83-92. doi: 10.2147/CEOR.S55265. eCollection 2014. Clinicoecon Outcomes Res. 2014. PMID: 24611019 Free PMC article.
Efficacy of ertapenem for treatment of bloodstream infections caused by extended-spectrum-β-lactamase-producing Enterobacteriaceae.
Collins VL, Marchaim D, Pogue JM, Moshos J, Bheemreddy S, Sunkara B, Shallal A, Chugh N, Eiseler S, Bhargava P, Blunden C, Lephart PR, Memon BI, Hayakawa K, Abreu-Lanfranco O, Chopra T, Munoz-Price LS, Carmeli Y, Kaye KS. Collins VL, et al. Antimicrob Agents Chemother. 2012 Apr;56(4):2173-7. doi: 10.1128/AAC.05913-11. Epub 2012 Jan 30. Antimicrob Agents Chemother. 2012. PMID: 22290982 Free PMC article.
Guidelines for the management of adult lower respiratory tract infections--full version.
Woodhead M, Blasi F, Ewig S, Garau J, Huchon G, Ieven M, Ortqvist A, Schaberg T, Torres A, van der Heijden G, Read R, Verheij TJ; Joint Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases. Woodhead M, et al. Clin Microbiol Infect. 2011 Nov;17 Suppl 6(Suppl 6):E1-59. doi: 10.1111/j.1469-0691.2011.03672.x. Clin Microbiol Infect. 2011. PMID: 21951385 Free PMC article.

A prospective, randomized, double-blind multicenter comparison of parenteral ertapenem and ceftriaxone for the treatment of hospitalized adults with community-acquired pneumonia - PubMed (original) (raw)