Cethromycin versus clarithromycin for community acquired pneumonia: The comparative efficacy and safety outcomes of two double-blinded, randomized, parallel group, multi-center, multi-national non-inferiority studies.

Link to article at PubMed

Cethromycin versus clarithromycin for community acquired pneumonia: The comparative efficacy and safety outcomes of two double-blinded, randomized, parallel group, multi-center, multi-national non-inferiority studies.

Antimicrob Agents Chemother. 2012 Jan 30;

Authors: English ML, Fredericks CE, Milanesio NA, Rohowsky N, Xu ZQ, Jenta TR, Flavin MT, Eiznhamer DA

Abstract
Community acquired pneumonia (CAP) continues to be a major health challenge in the US and globally. Factors such as overprescribing and non-compliance with antibiotics have added to the growing antibacterial resistance problem. In addition, several agents available for the treatment of CAP have been associated with serious side effects. Cethromycin is a new ketolide antibiotic that may provide prescribing physicians with an additional agent to supplement a continually limited armamentarium. Two global Phase III non-inferiority studies (CL05-001 and CL06-001) to evaluate cethromycin safety and efficacy were designed and conducted in patients with mild-to-moderate CAP. Study CL05-001 demonstrated 83.1% clinical cure rate in cethromycin group compared with 81.1% in clarithromycin group [95% CI: -4.8%, +8.9%] in the ITT population and 94.0% cethromycin clinical cure rate compared with 93.8% clarithromycin cure rate [95% CI: -4.5%, +5.1%] in the PPc population. Study CL06-001 achieved 82.9% cethromycin clinical cure rate in the ITT population compared with 88.5% clarithromycin cure rate [95% CI: -11.9%, +0.6%], whereas the clinical cure rate in the PPc population was 91.5% in cethromycin group compared with 95.9% in clarithromycin group [95% CI: -9.1%, +0.3%]. Both studies met the primary endpoints for clinical cure rate based on pre-defined, sliding-scale non-inferiority design. Therefore, in comparison with clarithromycin, these two non-inferiority studies demonstrated the efficacy and safety of cethromycin, with encouraging findings of efficacy in subjects with S. pneumoniae bacteremia. No clinically significant adverse events were observed during the studies. Cethromycin may be a potential oral therapy for the outpatient treatment of CAP.

PMID: 22290969 [PubMed - as supplied by publisher]

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