Table 1.

Study Design Characteristics

Characteristic	OASIS-1	OASIS-2
Treatment duration	7–14 days	7–14 days
Omadacycline dosing	100 mg IV q12h for 2 doses, then 100 mg IV q24h for 2 days Optional at >3 days: transition to 300 mg PO q24ha	450 mg PO q24h for 2 doses, then 300 mg PO q24h
Linezolid dosing	600 mg IV q12h Optional at >3 days: transition to 600 mg PO q12h	600 mg PO q12h
FDA primary endpointb	ECR at 48–72 h	ECR at 48–72 h
EMA primary endpointc	Investigator-assessed clinical response at PTE	Investigator-assessed clinical response at PTE
Prior antibiotics prohibited	Within 72 h of randomization, any other systemic or topical antibiotic agent potentially effective for ABSSSI	Within 72 h of randomization, any other systemic or topical antibiotic agent potentially effective for ABSSSId
Concomitant antibiotics prohibited	Any other systemic antibiotic against known/suspected ABSSSI pathogens, except in cases of clinical failure Any topical antibacterial agent active against known/suspected ABSSSI pathogen on study infection	Any other systemic antibiotic agent potentially effective for ABSSSI, except in cases of clinical failure Any topical antibacterial agent active against known/ suspected ABSSSI pathogen on study infection

Abbreviations: ABSSSI, acute bacterial skin and skin structure infections; ECR, early clinical response; EMA, European Medicines Agency; FDA, Food and Drug Administration; IV, intravenous; OASIS, Omadacycline in Acute Skin and Skin Structure Infections Study; PO, oral; PTE, posttreatment evaluation; q12h, every 12 hours; q24h, every 24 hours.

^aA transition from the IV to PO study drug was an option if there was evidence of local and systemic improvement (eg, temperature ≤100°F, return of white blood cell count and differential toward normal range, no increase in lesion area compared with baseline, and decrease in extent and intensity of ≥1 inflammatory finding).

^bECR was defined as: patient alive, with a reduction in lesion area of ≥20% vs baseline and no receipt of rescue antibacterial therapy.

^cPTE occurred at 7–14 days after treatment initiation.

^dA single dose of short-acting non-oxazolidinone antibacterial administered within 72 h prior to randomization was allowed for ≤25% of patients.