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

Abstract

BackgroundSwitch 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).MethodsA 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.ResultsIn 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.ConclusionsSwitch 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 IdentifierNCT00081575

Earlier switching from intravenous to oral antibiotics owing to electronic reminders

“…The present findings have important implications, since a lower risk for catheter-associated infections, reduced nursing workload, and decreased direct and indirect costs are associated with early IV-PO switches (4,5,(7)(8)(9). The proposed CDS algorithm allows for the implementation in most inpatient specialties with an openend intervention period; no manpower is required for the continued operation of the electronic reminders within the clinical information system, and a similar reminder could also be implemented in other hospitals.…”

“…Under consideration of anticipated improvements due to the intervention (increase patient safety, reduce workload and costs) (2,4,5,(7)(8)(9) and of available studies with similar interventions that reported no higher incidence of adverse events, (9,11,13,18) a waiver for informed consent was requested, because (i) limiting the study to patients who could give informed consent would decrease the generalizability of the results, and (ii) even attempting to obtain informed consent from such a large number of patients would result in financial costs that are prohibitive and a potentially poor use of limited resources. The study was registered at ClinicalTrials.gov (NCT01499927).…”

“…Such IV-PO switches are often considered approximately three days after starting the empiric therapy if the patient is clinically stable and is able to swallow (6,7). Changing the administration route may be performed while ordering the same or a different antimicrobial agent, depending on the microbiological susceptibility results.…”

“…Lower risk of catheter-associated infections, reduced nursing workload, and decreased direct and indirect costs (5,(7)(8)(9). A number of studies demonstrated reduced durations of the initial IV therapies due to paperbased checklists fostering the IV-PO switch (9-11).…”

Time to clinical stability in patients with ventilator-associated pneumonia due to Methicillin-resistant staphylococcus aureus treated with Linezolid versus Vancomycin: results from the IMPAC-HAP study

“…13 In the field of clinical research on CAP, time to clinical stability has been used as a clinical outcome to compare effectiveness of initial intravenous antibiotics. 15 During the initial 7 days of antimicrobial therapy, a number of patients will reach clinical stability. It can be hypothesized that those antibiotics with better activity against the etiologic organism may produce an early time to clinical stability and therefore increase the number of patients reaching clinical stability by day 7.…”