Table 1.

Characteristics of the main studies included.

	Study, Year Published	Study Design	Study Duration	Study Site	Study Population			No. of Patients (ITT Population)		Dose Regimen
					Total	UTI	%KPCp	Studied drug	Comparator	Studied drug	Comparator
CEFIDEROCOL: FETROJA®	Portsmouth et al., 2018 [29]	Phase 2, Double-blind, non-inferiority trial	2015–2016	65 hospitals in 15 countries	Adults with Gram-negative cUTI	100%	30%	300	148	1-h infusion of cefiderocol (2 g) every 8 h for 7–14 days	1-h infusion of imipenem/cilastatin (1 g each) every 8 h for 7–14 days
	Bassetti et al., 2021 [26] (CREDIBLE-CR trial)	Phase 3, Randomised, open-label, pathogen-focused, descriptive trial	2016–2019	95 hospitals in 16 countries	Adults with NP, BSI or sepsis, or cUTI and a CR-Gram-negative pathogen	24%	26%	101	49	3-h infusion of cefiderocol (2 g) every 8 h for 7–14 days	Best available therapy for 7–14 days
MEROPENEM/ VABORBACTAM: VABOREM®	Kaye et al., 2018 [37] (TANGO I CR-trial)	Phase 3, multicenter, multinational, randomised clinical trial, double blind trial	2014–2016	60 hospitals in 17 countries	Adults with complicated UTI, stratified by infection type and geographic region	100%	11%	274	276	Meropenem-vaborbactam (2 g/2 g over 3 h	Piperacillin-tazobactam (4 g/0.5 g over 30 min; every 8 h
	Wunderink et al., 2018 [38] (TANGO II CR-trial)	Phase 3, multinational, open-label, randomized controlled trial	2014–2017	27 hospitals in 8 countries	Adults with infections due to confirmed/suspected CRE	16%	87%	32	15	Meropenem–vaborbactam (2 g/2 g over 3 h, q8h for 7–14 days)	BAT (mono/combination therapy with polymyxins, carbapenems, aminoglycosides, tigecycline; or ceftazidime–avibactam alone)
CEFTAZIDIME-AVIBACTAM: ZAVICEFTA®	King et al., 2017 [46]	Multicenter, retrospective review	2015–2016	9 health systems in the United States	Adults who received at least 24 h of ceftazidime–avibactam therapy for CRE infection	28%	83%	29	21	Dosis of ceftazidime–avibactam was determined by providers at each site based on manufacturer’s-recommended dosing	Concomitant therapy and prior therapy for CRE infections were recorded
	Carmeli et al., 2016 [51] (REPRISE)	Phase 3; international, randomised, open-label trial	2013–2014	Hospitals across 16 countries worldwide	Adults with cUTI or cIAI caused by ceftazidime-resistant Enterobacteriaceae or Pseudomonas aeruginosa.	92%	38%	165	168	Combination of 2000 mg ceftazidime plus 500 mg avibactam, administered via a 2-h intravenous infusion every 8 h	BAT
IMIPENEM-CILASTATIN-RELEBACTAM: RECARBRIO®	Motsch et al., 2020 [59] (RESTORE-IMI 1)	Phase 3, Multicenter, Randomized, controlled Double-blind trial	2015–2017	35 hospitals in 17 countries	Adults hospitalized, and requiring intravenous antibacterial treatment for hospital-acquired pneumonia /ventilator-associated pneumonia, cUTIs, or cIAIs caused by imipenem-nonsusceptible, imipenem/relebactam-susceptible, and colistin-susceptible pathogens and lacking clinical improvement on any prior therapy.	51%	13%	21	10	Intravenous IMI/REL (500 mg/250 mg every 6 h) plus colistimethate sodium placebo	Intravenous IMI/REL (500 mg/250 mg every 6 h) plus intravenous colistimethate sodium (loading dose to achieve 300 mg colistin base activity, followed by maintenance doses up to 150 mg colistin base activity, every 12 h)