Table 2.

Summary of Study Designs for Key Studies in Support of Acute Bacterial Skin and Skin Structure Infections Indication

		RX-3341-201 (Study 201)	RX-3341-202 (Study 202)	RX-3341-302 (Study 302)	RX-3341-303 (Study 303)
Phase; year completed		Phase II; 2008	Phase II; 2011	Phase III; 2014	Phase III; 2016
Population		Adults with cSSSI (pre-2010 definition)	Adults with ABSSSI (required lesion size ≥75 cm2) and at least 1 systemic sign of infection	Adults with ABSSSI (required lesion size ≥75 cm2) and at least 2 systemic signs of infection	Adults with ABSSSI (required lesion size ≥75 cm2) and at least 2 systemic signs of infection
Comparator (N)		Tigecycline (50)	Linezolid (77) and vancomycin (98; optional aztreonam)	Vancomycin and aztreonam (329)	Vancomycin and aztreonam (427)
Delafloxacin dose/route (N)		300 mg IV Q12 h (49), 450 mg IV Q12 h (51)	300 mg IV Q12 h (81)	300 mg IV Q12 h (331)	300 mg IV Q12 h for 6 doses with switch to 450 mg oral Q12 h (423)
Duration of therapy		5–14 d	5–14 d	5–14 d	5–14 d
Time points	OR	NA	48–72 h	48–72 h	48–72 h
	EOT	NA	NA	Assessment collected	Assessment collected
	FU	NA	Day 14	Day 14	Day 14
	LFU	NA	Day 21–28	Day 21–28	Day 21–28
	TOC	14–21 days post– last dose	NA	NA	NA
Stratification factors and enrollment limits at randomization		Infection type	Infection type and prior antibiotics enrollment limited to: prior antibiotics − 30%, abscesses − 30%	Infection type enrollment limited to: prior antibiotics − 25%, abscesses − 25%, wounds − 35%	Infection type and BMI (< or ≥ 30 kg/m2). Enrollment limited to: prior antibiotics − 25%, abscesses − 25%, wounds − 30%, BMI ≥ 30 kg/m2− ≤ 50%
Primary endpoint		Investigator outcome (traditional definition, with complete or near resolution of signs and symptoms as cure)	Investigator assessment of cure only (similar to the Phase III studies, cure was classified as a success and all other responses were classified as failures [ie, improved, failure, and indeterminate]).	Objective response at 48–72 h (at least 20% reduction in lesion size, with no non-study medicines, major procedures, or death)	Objective response at 48–72 h (at least 20% reduction in lesion size, with no non-study medicines, major procedures, or death)
Key clinical efficacy secondary endpoint		NA	Clinical success cessation: cessation of lesion spread at 48–72 h, with resolution or absence of fever. Both must be sustained through 72 h. Clinical success reduction: reduction of lesion size (reported in 10% increments) at other time points, including 48–72 h.	Investigator assessment of response of signs and symptoms of infection at the FU and LFU visits. Cure was the primary analysis.	Investigator assessment of response of signs and symptoms of infection at the FU and LFU visits. Cure was the primary analysis.

Abbreviations: ABSSSI, acute bacterial skin and skin structure infections; BMI, body mass index; EOT, end of treatment; FU, follow-up; IV, intravenous; LFU, late follow-up; NA, not available; OR, objective response; TOC, test of cure.