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Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study.

ABSTRACT: The 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.Patients 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.The 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.This study highlights the significance of early evaluation of patients in hospitals, in potentially preventing prolonged use of inappropriate or ineffective antibacterial therapy.NCT01293435 .

SUBMITTER: Garau J

PROVIDER: S-EPMC4352248 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study.

Garau Javier J Blasi Francesco F Medina Jesús J McBride Kyle K Ostermann Helmut H

BMC infectious diseases 20150219

<h4>Background</h4>The 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 wit ...[more]

PMID: 25879713

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Project description:OBJECTIVES:Skin and soft tissue infections (SSTIs) carry significant economic burden, as well as morbidity and mortality, especially when caused by methicillin-resistant Staphylococcus aureus (MRSA). Several new MRSA-active antibiotics have been developed, including semisynthetic glycopeptides (telavancin, dalbavancin and oritavancin). Of these, dalbavancin and oritavancin offer extended dosing intervals. METHODS:We performed a systematic review, network meta-analysis and cost analysis to compare the newer glycopeptides to standard care and to each other for the treatment of complicated SSTIs (cSSTI). A search for randomized controlled trials (RCTs) was conducted in Medline, Embase and the Cochrane Central Register of Controlled Trials. We also developed a model to evaluate the costs associated with dalbavancin and oritavancin from the third-party payer perspective. RESULTS:Seven RCTs met the inclusion criteria. Network meta-analyses suggested that the clinical response to telavancin, dalbavancin and oritavancin was similar to standard care (odds ratio (OR) 1.09, 95% confidence interval (CI) 0.90-1.33; OR 0.78, 95% CI 0.52-1.18; and OR 1.06, 95% CI 0.85-1.33, respectively). Head-to-head comparisons showed no difference in clinical response between oritavancin and dalbavancin (OR 1.36; 95% CI 0.85-2.18), oritavancin and telavancin (OR 0.98; 95% CI 0.72-1.31) or dalbavancin and telavancin (OR 0.72; 95% CI 0.45-1.13). Telavancin had a higher incidence of overall adverse events compared to standard care (OR 1.33; 95% CI 1.10-1.61). Compared to telavancin, there were fewer overall adverse events with dalbavancin (OR 0.58; 95% CI 0.45-0.76) and oritavancin (OR 0.71; 95% CI 0.55-0.92). Studies were of high quality overall. Our cost analyses demonstrated that dalbavancin and oritavancin were less costly compared to standard care under baseline assumptions and many scenarios evaluated. The use of dalbavancin could save third-party payers $1442 to $4803 per cSSTI, while the use of oritavancin could save $3571 to $6932 per cSSTI. CONCLUSIONS:Dalbavancin and oritavancin demonstrate efficacy and safety comparable to standard care in well-designed RCTs and result in cost savings when standard care is treatment that covers MRSA.

Project description:BackgroundSkin and soft tissue infections (SSTIs) in hospital and community settings impose a substantial socio-economic burden. Therapeutic uncertainty due to the availability of a wide range of antibiotics and the need for empirical treatment decisions complicate SSTI clinical management. Completion of numerous pairwise meta-analyses to account for this variability in antibiotics is impractical, and many head-to-head comparisons of potential interest are likely not available. In comparing multiple antibiotics simultaneously, this network meta-analysis aims to identify the antibiotic(s) with the greatest value in the treatment of SSTIs, in terms of patient-important outcomes such as efficacy and safety.MethodsWe will conduct a systematic review to identify randomized controlled trials of persons with suspected or confirmed SSTI assigned to orally or parenterally administered antibiotic therapy that report results on at least one outcome of interest. We will search MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL), along with trial registries. Our primary outcome of interest is clinical success at the test-of-cure visit. Secondary outcomes may include (1) early clinical success (2-3 days after the therapy starts), (2) mortality, (3) adverse events, (4) treatment duration, and (5) length of hospital stay. Independent reviewers will complete screening of titles, abstracts, and full texts, data extraction, risk of bias assessment (using the Cochrane Risk of Bias tool), and evaluation of the certainty of evidence (using the GRADE approach) in duplicate. We will complete pairwise and network meta-analyses within the Bayesian framework when possible using a random effects model. We will stratify SSTIs by severity into uncomplicated and complicated SSTIs when possible. Subgroup analyses by age, infection type, comorbidity, and suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA)-associated infection are planned.DiscussionThis study has several strengths compared to previous reviews: inclusion of a wider range of infection types, antibiotics, and outcomes; a comprehensive search strategy; a priori subgroup analyses; application of GRADE; and improved interpretability of findings through visual presentation of results. We hope our findings will inform future research, health care professionals, and policy makers resulting in improved evidence-based clinical management of SSTIs.Systematic review registrationPROSPERO CRD42018085607.

Dataset Information

Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study.

Publications

Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study.

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