Dataset Information

Multicenter Study of the Real-World Use of Ceftaroline versus Vancomycin for Acute Bacterial Skin and Skin Structure Infections.

ABSTRACT: The objective of this study was to determine if real-world ceftaroline treatment in adults hospitalized for acute bacterial skin and skin structure infections (ABSSSI) is associated with decreased infection-related length of stay (LOS_inf) compared to that with vancomycin. This was a retrospective, multicenter, cohort study from 2012 to 2017. Cox proportional hazard regression, propensity score matching, and inverse probability of treatment weighting (IPTW) were used to determine the independent effect of treatment group on LOS_inf The patients were adults hospitalized with ABSSSI and treated with ceftaroline or vancomycin for ?72?h within 120?h of diagnosis at four academic medical centers and two community hospitals in Arizona, Florida, Michigan, and West Virginia. A total of 724 patients were included (325 ceftaroline treated and 399 vancomycin treated). In general, ceftaroline-treated patients had characteristics consistent with a higher risk of poor outcomes. The unadjusted median LOS_inf values were 5 (interquartile range [IQR], 3 to 7) days and 6 (IQR, 4 to 8) days in the vancomycin and ceftaroline groups, respectively (hazard ratio [HR], 0.866; 95% confidence interval [CI], 0.747 to 1.002). The Cox proportional hazard model (adjusted HR [aHR], 0.891; 95% CI, 0.748 to 1.060), propensity score-matched (aHR, 0.955; 95% CI, 0.786 to 1.159), and IPTW (aHR, 0.918; 95% CI, 0.793 to 1.063) analyses demonstrated no significant difference in LOS_inf between groups. Patients treated with ceftaroline were significantly more likely to meet criteria for discharge readiness at day 3 in unadjusted and adjusted analyses. Although discharge readiness at day 3 was higher in ceftaroline-treated patients, LOS_inf values were similar between treatment groups. Clinical and nonclinical factors were associated with LOS_inf.

SUBMITTER: Trinh TD

PROVIDER: S-EPMC6811452 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Multicenter Study of the Real-World Use of Ceftaroline versus Vancomycin for Acute Bacterial Skin and Skin Structure Infections.

Trinh T D TD Jorgensen S C J SCJ Zasowski E J EJ Claeys K C KC Lagnf A M AM Estrada S J SJ Delaportes D J DJ Huang V V Klinker K P KP Kaye K S KS Davis S L SL Rybak M J MJ

Antimicrobial agents and chemotherapy 20191022 11

The objective of this study was to determine if real-world ceftaroline treatment in adults hospitalized for acute bacterial skin and skin structure infections (ABSSSI) is associated with decreased infection-related length of stay (LOS<sub>inf</sub>) compared to that with vancomycin. This was a retrospective, multicenter, cohort study from 2012 to 2017. Cox proportional hazard regression, propensity score matching, and inverse probability of treatment weighting (IPTW) were used to determine the i ...[more]

PMID: 31405859

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Project description:INTRODUCTION:Acute bacterial skin and skin structure infections (ABSSSIs) remain among the most common infectious processes seen in the clinical setting. For patients with complicated ABSSSIs deemed to require intravenous antibiotics, vancomycin remains the mainstay therapy. Ceftaroline has been shown to be non-inferior to vancomycin and may result in faster resolution of signs of infection. METHODS:Multicenter, prospective, open-label, randomized trial of ceftaroline versus vancomycin for the treatment of adult patients admitted for management of ABSSSIs from April 2012 to May 2016; 166 patients in the clinically evaluable (CE) group were needed to determine a 20% difference in primary outcome of clinical response at day 2 or 3 of antibiotics. Clinical response was defined as cessation of spread of lesion and improvement in systemic signs/symptoms of infection. A secondary outcome was a ≥ 20% reduction in lesion size at day 2 or 3 of antibiotics. RESULTS:One hundred seventy-four patients were enrolled in the intention-to-treat (ITT) group and 108 were CE. Among CE patients, 54 were randomized to ceftaroline and 54 to vancomycin. Baseline characteristics were similar except patients in the ceftaroline arm were older and had a non-significantly higher degree of comorbidities (median Charlson score 2 vs. 4, respectively). Cellulitis was the most common type of ABSSSI (85.2% vs. 79.6%, respectively). Rapid diagnostic testing of available cultures (n = 55) demonstrated high agreement with clinical microbiology for identification of Staphylococcus aureus (100%) and MRSA (100%). There was no significant difference in primary outcome of day 2 or 3 clinical response (50.0% vs. 51.9%). CONCLUSION:Early clinical response between vancomycin- and ceftaroline-treated ABSSSIs was similar. Patients with ABSSSIs rarely remained hospitalized for > 2-3 days, thus limiting our ability to critically assess clinical outcomes. TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT02582203. FUNDING:Allergan plc.

Project description:BackgroundOmadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that was recently approved by the US Food and Drug Administration for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). In 2 phase 3 clinical trials, IV-to-oral switch and oral-only administration of omadacycline achieved the primary end points of noninferiority compared with linezolid in treating patients with ABSSSI.ObjectiveTo estimate the potential cost-savings with bioequivalent IV-to-oral antibiotics, such as omadacycline, compared with the standard of care with IV vancomycin by avoiding hospitalizations and reducing hospital stays in patients presenting from the emergency department for ABSSSI treatment.MethodsWe used hospital avoidance models to examine the potential cost-savings of managing patients with ABSSSI and no or limited comorbidities and without life-threatening conditions by using omadacycline in the outpatient setting compared with the current standard of care. Early hospital discharge models were used to evaluate the hospital stay reduction that would be required to be achieved with omadacycline treatment relative to IV vancomycin to confer cost-savings compared with standard of care among patients with ABSSSI and ?2 comorbidities but no life-threatening conditions.ResultsIn the hospital stay avoidance models, cost-savings may be realized by using therapeutically bioequivalent IV-to-oral antibiotics, such as omadacycline, compared with inpatient treatment with IV vancomycin. Based on a sensitivity analysis, further savings could be possible with outpatient administration of omadacycline, even if 20% of omadacycline outpatients were subsequently admitted and incurred the full inpatient cost, with no reimbursement penalties. Of more than 300 patients, only 1 was admitted to the hospital after a full course of omadacycline in the oral-only clinical trial. In the early hospital discharge models, the maximum cost-minimizing daily expense of omadacycline varied from $173 to $936, depending on the presence of active comorbidities or systemic symptoms, hospital stay reduction, and model perspective.ConclusionThese results suggest that the targeted use of antibiotics with bioequivalent IV-to-oral formulations, such as omadacycline, for select patients with ABSSSI may lead to cost-savings compared with inpatient IV vancomycin treatment by shifting care to the outpatient setting or by facilitating earlier hospital discharge among hospitalized patients.

Project description:AimExploratory analyses evaluated patient characteristics and outcomes among patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU).MethodsAdults with cSSTI (surface area ≥ 75 cm2) and evidence of systemic inflammation and/or underlying comorbidities were randomized 2:1 to intravenous ceftaroline fosamil (600 mg every 8 h [q8h]) or vancomycin (15 mg/kg every 12 h) plus aztreonam (1 g q8h) for 5-14 days. Clinical response and ICU length of stay (LOS) within first hospitalization were evaluated in the modified intent-to-treat (MITT) and clinically evaluable (CE) populations; a Cox proportional hazards model identified factors associated with increased hospital LOS.ResultsOverall, 42 of 761 randomized patients were admitted to the ICU (ceftaroline fosamil, n = 32; vancomycin plus aztreonam, n = 10) prior to, or at start of, study treatment. Baseline differences between the ICU and non-ICU populations were indicative of more severe disease in ICU patients; within this subset, there were also some notable imbalances between treatment groups. Clinical cure rates at test-of-cure (ceftaroline fosamil vs. vancomycin plus aztreonam) were generally similar in the non-ICU and ICU subsets (MITT population 79% vs. 79% and 69% vs. 90.0%, respectively; CE population 87% vs. 85% and 80% vs. 89%, respectively). Median ICU LOS was 8 vs. 13 days, respectively. ICU admission was a risk factor predicting increased hospital LOS (P < 0.001).ConclusionsClinical outcomes for patients admitted to the ICU were generally similar to non-ICU patients, despite more severe baseline disease, with shorter median treatment duration in the ceftaroline fosamil group. ICU admission was associated with longer hospital LOS. Given the small sample size and unbalanced patient and disease characteristics within the ICU subgroup, differences between treatment groups should be interpreted with caution.Trial registrationClinicalTrials.gov identifier, NCT01499277.

Dataset Information

Multicenter Study of the Real-World Use of Ceftaroline versus Vancomycin for Acute Bacterial Skin and Skin Structure Infections.

Publications

Multicenter Study of the Real-World Use of Ceftaroline versus Vancomycin for Acute Bacterial Skin and Skin Structure Infections.

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