Randomized Controlled Noninferiority Trial Comparing Daptomycin to Vancomycin for the Treatment of Complicated Skin and Skin Structure Infections in an Observation Unit.

BACKGROUND: Incidence of methicillin-resistant Staphylococcus aureus (MRSA) is increasing in complicated skin and skin structure infection (cSSSI) presenting to emergency departments (EDs). Treatment is heterogeneous and can require inpatient admission to an observation unit (OU). Vancomycin is commonly used in the OU for treatment, but increasing MRSA resistance to vancomycin suggests the need for alternatives. Daptomycin is an alternative but it is not known how it compares with vancomycin. OBJECTIVE: This study tested the hypothesis that daptomycin is noninferior to vancomycin for the treatment of cSSSI in an OU, using a relative risk (RR) of 1.3 as the noninferiority limit. METHODS: Subjects admitted to an ED-based OU with a diagnosis of cSSSI were eligible. Consenting subjects were randomized 1:1 to intravenous (i.v.) vancomycin at 15 mg/kg dosing every 12 h or i.v. daptomycin at 4 mg/kg once. Subjects were followed until they met objective criteria for discharge home or hospital admission. Discharged patients were prescribed 10-14 days of oral cephalexin and trimethoprim-sulfamethoxazole, or clindamycin if allergic to either of these medications. The primary endpoint was meeting objective discharge criteria with no change in antibiotic therapy or return to the ED for the same cellulitis within 30 days of OU discharge. RESULTS: There were 100 patients enrolled. RR for satisfying the endpoint was 1.07 (95% confidence interval 0.58-1.98) for daptomycin compared with vancomycin. Hospital admission rates were 36% and 32% for daptomycin and vancomycin treatment, respectively. CONCLUSION: Daptomycin was not inferior to vancomycin in the treatment of cSSSI in an OU.

Prevalence of prehospital hypoxemia and oxygen use in trauma patients.

OBJECTIVE: This study estimates the prevalence of injured patients requiring prehospital supplemental oxygen based on existing recommendations, and determines whether actual use exceeds those recommendations. PATIENTS AND METHODS: Prehospital oxygen use and continuous peripheral oxygen saturation measurements were prospectively collected on a purposive sample of injured civilians transported to an urban level 1 trauma center by paramedics. Structured chart review determined injury characteristics and outcomes. Supplemental oxygen administration indications were hypoxemia (peripheral oxygen saturation ≤ 90%), hemorrhagic shock (systolic blood pressure < 100 mmHg), or paramedic suspicion of traumatic brain injury. RESULTS: Paramedics enrolled 224/290 screened subjects. Median (range) age was 34 (18-84) years, 48.7% were nonwhite, 75.4% were male, and Injury Severity Score was 5 (1-75). Half (54.5%) were admitted; 36.2% sustained a penetrating injury. None underwent prehospital endotracheal intubation. Hypoxemia occurred in 86 (38.4%), paramedics suspected traumatic brain injury in 22 (9.8%), and 20 (8.9%) were hypotensive. Any indication for supplemental oxygen (107/224 [47.8%, 95%CI 41.3%-54.3%]) and prehospital administration of oxygen (141/224 [62.9%, 95%CI 56.2%-69.2%]) was common. Many (35/141 [24.8%]) received oxygen without indication. CONCLUSIONS: On the basis of current guidelines, less than half of adult trauma patients have an indication for prehospital supplemental oxygen, yet is frequently administered in the absence of clinical indication.