Table 1.

Studies in patients with acute bacterial skin and skin structure infections treated with dalbavancin or a comparator agent

Study number and title	Treatment	Dose adjustments for renal insufficiencya
DUR001-301 (DISCOVER trial) NCT01339091
Phase 3, randomized, double-blind, double-dummy study to compare the efficacy and safety of dalbavancin to a comparator regimen (vancomycin with possible switch to orally administered linezolid) for the treatment of acute bacterial skin and skin structure infections [17]	Intravenously administered dalbavancin: 1000 mg on day 1, 500 mg on day 8, IV placebo q12h to match vancomycin, possible switch to oral placebo q12h after 3 days IV therapy, treatment duration 10–14 days IV comparator: intravenously administered vancomycin 1000 mg or 15 mg/kg q12h, IV placebo to match dalbavancin, possible switch to orally administered linezolid 600 mg q12h after 3 days IV vancomycin therapy, treatment duration 10–14 days	Intravenously administered dalbavancin doses reduced to 750 mg on day 1 and 375 mg on day 8 Intravenously administered vancomycin dose adjustments were based on CrCl values, renal function, and vancomycin serum concentration
DUR001-302 (DISCOVER trial) NCT01431339
Phase 3, randomized, double-blind, double-dummy study to compare the efficacy and safety of dalbavancin to a comparator regimen (vancomycin with possible switch to orally administered linezolid) for the treatment of acute bacterial skin and skin structure infections [17]	Intravenously administered dalbavancin: 1000 mg on day 1, 500 mg on day 8, IV placebo q12h to match vancomycin, possible switch to oral placebo q12h after 3 days IV therapy, treatment duration 10–14 days IV comparator: intravenously administered vancomycin 1000 mg or 15 mg/kg q12h, IV placebo to match dalbavancin, possible switch to orally administered linezolid 600 mg q12h after 3 days IV vancomycin therapy, treatment duration 10–14 days	Intravenously administered dalbavancin doses reduced to 750 mg on day 1 and 375 mg on day 8 Intravenously administered vancomycin dose adjustments were based on CrCl values, renal function, and vancomycin serum concentration
DUR001-303 NCT02127970
Phase 3b, double-blind, multicenter, randomized study to compare the efficacy and safety of single-dose dalbavancin to a two-dose regimen of dalbavancin for the treatment of acute bacterial skin and skin structure infections [16]	Intravenously administered dalbavancin, two-dose regimen: 1000 mg on day 1, 500 mg on day 8 Intravenously administered dalbavancin, single-dose regimen: 1500 mg on day 1, placebo to match dalbavancin on day 8	Intravenously administered dalbavancin, two-dose regimen: 750 mg on day 1, 375 mg on day 8 Intravenously administered dalbavancin, single-dose regimen: 1000 mg on day 1

CrCl creatinine clearance, IV intravenous, q12h every 12 h

^aDosage adjustments for patients with CrCl < 30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis; dosage adjustments for vancomycin were based on the study site standard of care