A Randomized Clinical Trial of Single Dose vs Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection.
Clin Infect Dis. 2015 Nov 26;
Authors: Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M, Baldassarre J
BACKGROUND: Acute bacterial skin and skin structure infections (ABSSSI) are a cause of significant morbidity and therapy can be a burden to the healthcare system. New antibiotics that simplify treatment and avoid hospitalization are needed. This study compared the safety and efficacy of a single intravenous infusion of 1500 mg of dalbavancin to the two-dose regimen.
METHODS: This study was a randomized, double-blind trial in patients>18 years with ABSSSI. Patients were randomized to dalbavancin 1500 mg either as a single IV infusion or 1000 mg IV on Day 1 followed one week later by 500 mg IV. The primary endpoint was a ≥20% reduction in the area of erythema at 48-72 hours in the Intent to Treat (ITT) population. Non-inferiority was to be declared if the lower limit of the 95% confidence interval on the difference in the outcomes was >-10%. Clinical outcome was also assessed at Days 14 and 28.
RESULTS: 698 patients were randomized. Demographic characteristics were similar on each regimen though there were more patients with a methicillin-resistant Staphylococcus aureus (MRSA) at baseline on the two-dose regimen [36/210 (17.1%) vs 61/220 (27.7%)]. Dalbavancin delivered as a single dose was non-inferior to a two dose regimen (81.4% vs 84.2%; difference -2.9%; 95%CI: -8.5, 2.8). Clinical outcomes were also similar at Day 14 (84.0% vs 84.8%), Day 28 (84.5% vs 85.1%) and at Day 14 in clinically evaluable patients with MRSA in a baseline culture (92.9% vs.95.3%) in the single and two dose regimens, respectively. Treatment emergent adverse events (TEAE) occurred in 20.1% of the single dose patients and 19.9% on the two dose regimen.
CONCLUSIONS: A single 1500 mg infusion of dalbavancin is non-inferior to a two-dose regimen, has a similar safety profile and removes logistical constraints related to delivery of the second dose.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02127970.
PMID: 26611777 [PubMed - as supplied by publisher]