TABLE 5.

Summary of results from patients with unfavorable response at the TOC assessment among the ME patients enrolled in the cUTI and cIAI phase 2 trials for ceftazidime-avibactam

Triala	Armb	Patient no.	Age (yr)	Pathogen	MIC (μg/ml)			Molecular characterization
					CAZ	CAZ-AVI	MER/IMI
cUTI	CAZ-AVI	1	28	E. coli	1	0.12	0.12	CTX-M-14 + TEM-1
		2	36	E. coli	>32	0.25	0.12	CTX-M-15 + OXA-1 + TEM-1
		3	57	E. coli	8	0.12	0.12	CTX-M-15 + OXA-1
		4	36	P. aeruginosa	4	4	0.5	Screen negativec
	IMI	5	76	E. coli	32	0.12	0.06	CTX-M-15 + TEM-1
		6	34	E. coli	>32	0.12	0.12	CTX-M-15 + TEM-1
		7	45	E. coli	8	0.12	0.12	CTX-M-15 + TEM-1
		8	45	E. coli	0.5	0.12	0.12	Screen negative
		9	50	E. coli	16	0.12	0.12	CTX-M-15 + TEM-1
				P. mirabilis	≤0.03	≤0.03	0.25	Screen negative
		10	68	E. coli	0.12	0.06	0.12	Screen negative
		11	71	E. cloacae	>32	2	0.25	Upregulated AmpC + TEM-1
cIAI	CAZ-AVI/MTZ	1	52	E. coli	16	≤0.03	≤0.004	CTX-M-15 + OXA-1 + SHV-2
		2	40	E. coli	>32	2	0.015	CTX-M-15 + OXA-1 + CMY-42
		3	49	E. coli	0.25	0.12	0.015	Screen negative
		4	30	E. coli	0.06	≤0.03	0.008	Screen negative
		5	33	E. coli	0.12	0.12	0.015	Screen negative
	MER	6	20	E. coli	>32	0.12	0.015	CTX-M-15 + OXA-1 + SHV-12 + TEM-1
		7	82	E. aerogenes	0.12	0.12	0.03	Screen negative
		8	39	E. coli	0.12	0.06	0.015	Screen negative
		9	69	E. coli	0.12	0.06	0.015	Screen negative
		10	26	E. coli	0.12	0.06	0.015	Screen negative

^acUTI, complicated urinary tract infection; cIAI, complicated intra-abdominal infection.

^bCAZ, ceftazidime; CAZ-AVI, ceftazidime-avibactam; MER, meropenem; IMI, imipenem.

^cScreen negative, isolates that did not meet the MIC-based screening criteria.

^d Patient with polymicrobial infections (E. coli-P. mirabilis) at baseline. A molecularly unrelated (PFGE) E. coli isolate (CTX-M-15 + OXA-1) was recovered at visit 5.

^e A CTX-M-15-producing E. coli isolate was recovered at visit 5.

^f A molecularly unrelated (by PFGE) E. coli isolate (NDM-1 + CTX-M-15 + OXA-1 + CMY-2) was recovered at the follow-up visit.