Email updates

Keep up to date with the latest news and content from BMC Infectious Diseases and BioMed Central.

Open Access Research article

Switch therapy in hospitalized patients with community-acquired pneumonia: Tigecycline vs. Levofloxacin

Julio A Ramirez13*, Angel C Cooper2, Timothy Wiemken1, David Gardiner2, Timothy Babinchak2 and For the 308 Study Group

Author Affiliations

1 University of Louisville, Louisville, KY, USA

2 Pfizer Inc, Collegeville, PA, USA

3 Division of Infectious Diseases, University of Louisville, 501 E Broadway Suite 308, Louisville, KY, 40202, USA

For all author emails, please log on.

BMC Infectious Diseases 2012, 12:159  doi:10.1186/1471-2334-12-159

Published: 19 July 2012

Abstract

Background

Switch therapy is a management approach combining early discontinuation of intravenous (IV) antibiotics, switch to oral antibiotics, and early hospital discharge. This analysis compares switch therapy using tigecycline versus levofloxacin in hospitalized patients with community-acquired pneumonia (CAP).

Methods

A prospective, randomized, double-blind, Phase 3 clinical trial; patients were randomized to IV tigecycline (100 mg, then 50 mg q12h) or IV levofloxacin (500 mg q24h). Objective criteria were used to define time to switch therapy; patients were switched to oral levofloxacin after ≥6 IV doses if criteria met. Switch therapy outcomes were assessed within the clinically evaluable (CE) population.

Results

In the CE population, 138 patients were treated with IV tigecycline and 156 were treated with IV levofloxacin. The proportion of the population that met switch therapy criteria was 67.4% (93/138) for tigecycline and 66.7% (104/156) for levofloxacin. The proportion that actually switched to oral therapy was 89.9% (124/138) for tigecycline and 87.8% (137/156) for levofloxacin. Median time to actual switch therapy was 5.0 days each for tigecycline and levofloxacin. Clinical cure rates for patients who switched were 96.8% for tigecycline and 95.6% for levofloxacin. Corresponding cure rates for those that met switch criteria were 95.7% for tigecycline and 92.3% for levofloxacin.

Conclusions

Switch therapy outcomes in hospitalized patients with CAP receiving initial IV therapy with tigecycline are comparable to those of patients receiving initial IV therapy with levofloxacin. These data support the use of IV tigecycline in hospitalized patients with CAP when the switch therapy approach is considered.

ClinicalTrials.gov Identifier

NCT00081575

Keywords:
Tigecycline; Levofloxacin; CAP; Oral switch