Abstract
BackgroundThe treatment of complicated skin and soft tissue infections (cSSTI) is challenging and many patients do not receive adequate first-line therapy. REACH (REtrospective Study to Assess the Clinical Management of Patients With Moderate-to-Severe cSSTI or Community-Acquired Pneumonia in the Hospital Setting) was a retrospective observational study of cSSTI patients in real-life settings in European hospitals. In this analysis, we review characteristics and outcomes of patients with an early response (≤72 hours) compared with those without an early response to treatment. We also compare the results according to two differing definitions of early response, one of which (Definition 1) requires resolution of fever within 72 hours, in line with previous US FDA guidelines.MethodsPatients were adults hospitalized with cSSTIs 2010–2011 and requiring treatment with intravenous antibiotics. Clinical management, clinical outcomes and healthcare resource use were assessed using a descriptive analysis approach.ResultsThe analysis set included 600 patients, of which 363 showed early response with Definition 1 and 417 with Definition 2. Initial treatment modification was frequent, and highest in patients without early response (48.1% with Definition 1). Patients without early response were more likely to have diabetes than those with early response (31.6% vs. 22.9%, respectively) and to suffer from more severe disease (e.g. skin necrosis: 14.8% and 7.7%, respectively), to be infected with difficult-to-treat microorganisms and to have recurrent infections. Furthermore, patients without early response had a higher rate of adverse clinical outcomes (e.g. septic shock) and higher use of healthcare resources. The results obtained with the two definitions for early response were largely similar.ConclusionsThis study highlights the significance of early evaluation of patients in hospitals, in potentially preventing prolonged use of inappropriate or ineffective antibacterial therapy.Trial registrationNCT01293435.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-015-0822-2) contains supplementary material, which is available to authorized users.
Highlights
The treatment of complicated skin and soft tissue infections is challenging and many patients do not receive adequate first-line therapy
Complicated skin and soft tissue infections represent a heterogeneous range of diseases, from severe infections affecting otherwise healthy patients, to relatively minor infections affecting patients with several comorbidities [1]. complicated skin and soft tissue infections (cSSTI) are reported to be among the most common infections treated in the hospital setting [2], both in the UK, where they account for at least 10% of admissions to infection units [3], and in the USA, where hospital admissions for cSSTI increased by 29% from 2000–2004 [4]
Treatment of cSSTIs is typically empirical, and earlier studies have shown high rates of initial treatment failure in patients hospitalized with cSSTI [5,6]
Summary
The treatment of complicated skin and soft tissue infections (cSSTI) is challenging and many patients do not receive adequate first-line therapy. In 2010, the US Food and Drug Administration (FDA) issued draft guidance recommending a new primary endpoint for industrial development of antimicrobials used for the treatment of acute bacterial skin and soft structure infection (ABSSSI) to be defined at 48–72 hours instead of the traditional test-of-cure [9]. This earlier time point could be more clinically relevant, as it would allow early identification of treatment success or failure and prevent prolonged use of inappropriate or ineffective antibacterial therapy, which is shown to be associated with adverse outcomes [6]. The FDA recommended endpoint includes co-primary outcomes of the resolution of fever and the cessation of the spread of the lesion after approximately 48–72 hours of antibacterial therapy [9]
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