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Table 2 Summary of included studies

From: Real-world use of ceftolozane/tazobactam: a systematic literature review

Citation, study design, location N C/T Patient/infection description Disease severity C/T treatment Outcome, % (n/N)
Clinical Micro Mortality
2020 Studies
Peer-reviewed literature
 Bassetti et al. 2020 [18]
Retrospective, multicenter
Italy
153 ESBL-producing Enterobacterales infections, including NP (30.0%), cUTI (22.2%), and cIAI (16.3%) ICU N = 74
CCI mean = 4.9
Dose C/T: 1.5 g q8h (75.0; of which 6 patients received creatinine clearance adjusted dose) or 3 g q8h (24.8%)
Empiric C/T: 30.0%
Confirmed C/T: 70.0%
Duration: med. (range): 14 (8–25) days
83.7
(128/153)
9.8
(15/153)
 Bosaeed et al. 2020 [19]
Retrospective, single center
Saudi Arabia
19 MDR PsA infections, including
NP (32%), CLABSI (21%), and
ABSSSI (16%), and cIAI (16%)
ICU N = 12 Dose C/T: 1.5 g q8h (42.1%) or 3 g q8h (10.5%) or creatinine clearance adjusted (47.4%)
Duration: med. (range): 14 (7–35) days
95
(18/19)
74
(14/19)
21
(4/19)
 Buonomo et al. 2020 [20]
Retrospective, single center
case series
Italy
4 PsA (50% MDR; 50% XDR) cSSTI in patients with chronic kidney disease - Dose C/T: creatine clearance adjusted (100.0%)—0.75 g q8h (75%), 0.375 g q8h (25%)
Empiric C/T: 0.0%
Confirmed C/T: 100.0%
Duration: med. (range): 14 (14) days
100.0
(4/4)
- 0
 Jones et al. 2020 [21]
Retrospective single center,
case series
US
7 PsA (57.1% non-MDR; 42.9% MDR) infections (one patient also had an E. coli infection), including pneumonia (42.9%), cUTI (28.6%), and bacteremia (14.3%) Dose C/T: 4.5 g qd (CI; 85.7%), 9 g qd (CI; 14.3%)
Duration: med. (range): 14 (6–42) days
85.7
(6/7)
100.0
(3/3)
0a
 Jorgensen et al. 2020 [22]
Retrospective, multicenter
US
259 MDR gram-negative infections (91.1% PsA; 23.2% Enterobacterales) including, RTIs (62.9%), SSTIs (10.8%), and UTIs (10.0%). Patients with MDR PsA infections (N = 226) were used as the primary analysis set ICU N = 131
IMC N = 23
APACHE II med. = 21
CCI med. = 3
SOFA med. = 5
Dose C/T: 1.5 g q8h (36.3%) or 3 g q8h (63.7%), creatinine clearance adjusted (30.5%)
Duration: med. (IQR): 10 (6–15) days
MDR PsA (N = 226)
Clinical failure:
37.6
(85/226)
- MDR PsA (N = 226)
17.3
(39/226)
 Vena et al. 2020 [23]
Retrospective, multicenter, case–control
Italy
16 Drug-resistant PsA (62.5% MDR; 37.5% XDR) pneumonia and bacteremia ICU N = 2 Duration: mean (SD): 12.1 (5.8) days 81.3
(13/16)
- 18.8
(3/16)
Conference proceedings        
 Caffrey et al. 2020 [80]
Retrospective, multicenter, cohort
US
57 MDR PsA infections, including RTIs (36.8%), UTIs (22.8%), and SSTIs (17.5%) ICU N = 36
APACHE II med. = 40
CCI med. = 4
Duration med. (IQR): 12 (5–18) days - 31.0
(13/42)
17.5
(10/57)
 Gudiol et al. 2020 [79]
Retrospective, multicenter
International
31 PsA (90.3% MDR; 41.9% XDR) bloodstream infections in neutropenic cancer patients ICU N = 7
IMC N = 31
Empiric C/T: 25.8%
Confirmed C/T: 96.8%
- - 16.1
(5/31)
2019 studies        
Peer-reviewed literature        
 Bassetti et al. 2019 [25]
Retrospective, multicenter
Italy
101 PsA (70% drug resistant) infections, including NP (31.7%), ABSSSI (20.8%), and cUTI (13.9%) ICU N = 24
CCI mean = 4.4
Dose C/T: 1.5 g q8h (69.3%) or 3 g q8h (30.7%)
Duration: med. (range): 14 (9–23) days
83.2
(84/101)
- 5.0
(5/101)
 Fernández-Cruz et al. 2019 [26]
Retrospective, single center, case–control
Spain
19 PsA (52.6% MDR; 47.4% XDR) infections, including pneumonia (26.3%), catheter-related BSI (21.1%), and primary BSI (21.1%) in patients with hematological malignancy ICU N = 5
IMC N = 19
CCI mean = 3.0
SOFA mean = 5.4
Empiric C/T: 15.8%
Confirmed C/T: 84.2%
Duration: med. (range): 14 (7–18) days
89.5
(17/19)
- 5.3
(1/19)
 Gerlach et al. 2019 [24]
Retrospective, single center
US
18 MDR PsA osteomyelitis ICU N = 11
APACHE II med. = 13.5
CCI med. = 5.5
Dose C/T: 1.5 g q8h (27.7%) or 3 g q8h (55.6%), or creatinine clearance adjusted (16.7%)
Empiric C/T: 0.0%
Confirmed C/T: 100.0%
Duration: med. (range): 39 (3–98) days
50.0
(9/18)
75.0
(3/4)
22.2
(4/18)
 Pogue et al. 2019 [27]
Retrospective, multicenter, case–control
US
100 MDR or XDR PsA infections, including NP (VABP [52.0%], HABP [12.0%]), cUTIs (16.0%), and wound (13.0%) ICU N = 70
IMC N = 14
CCI mean = 3
SOFA = 8
Dose C/T: 3 g q8h (63%), 1.5 g q8h (38%)
Duration: med. (IQR): 9.5 (7–14) days
81.0
(81/100)
- 20.0
(20/100)
 Rodriguez-Nunez et al. 2019 [28]
Retrospective, multicenter
International
90 Drug-resistant PsA RTIs (76.7% XDR; 23.3% MDR) CCI med. = 5 Dose C/T: standard (1.5 g q8h or creatinine clearance adjusted; 40%), high (3 g q8h or double creatinine clearance 60%)
Duration: med. (IQR): 14 (10–16) days
56.7
(51/90)
- 27.8
(25/90)
 Tan et al. 2019 [29]
Retrospective, single center, case series
US
5 MDR gram-negative (60% PsA; 40% A. baumannii) osteomyelitis - Dose C/T: 1.5 g q8h (20%), 3 g q8h (80%)
Empiric C/T: 0%
Confirmed C/T: 100%
Duration mean: 37.8 days
60.0
(3/5)
- 20.0
(1/5)
Conference proceedings        
 Cabrera et al. 2019 [85]
Retrospective, multicenter
US
45 Gram-negative (84.4% PsA; 71.1% MDR PsA) infections, including pneumonia (38%), UTI (20%), wound (9%), and bone (9%) ICU N = 19
IMC N = 6
Empiric C/T: 21.7%
Confirmed C/T: 78.3%
Duration med. (IQR): 8 (4–12) days
68.9
(31/45)
- 0
 Hart et al. 2019 [84]
Retrospective, multicenter
US
70 MDR PsA infections, including pneumonia (56%), wound (11%), IAI (10%) in immunocompromised patients ICU N = 33
IMC N = 70
APACHE II med. = 18
CCI med. = 5
Duration mean (SD): 13 (10.8) days 69
(48/70)
- 19
(13/70)
 Mills et al. 2019 [83]
Retrospective, multicenter cohort
US
62 MDR PsA pneumonia ICU N = 49
IMC N = 13
Duration mean: 16.1 days 72.6
(45/62)
- 29
(18/62)
 Sheffield et al. 2019 [82]
Retrospective, case series
US
4 PsA or ESBL-producing E. coli infections, including LVAD infection (50.0%), RTI (25.0%), and IAI (25.0%) - Dose C/T med.: 6 g CI qd
Duration range: 6–91 days
- - 0
 Trisler et al. 2019 [81]
Retrospective, multicenter
US
35 PsA infections, including RTI (71.4%), IAI (14.3%), and osteomyelitis (5.7%) in patients with and without CF - Empiric C/T: 0.0%
Confirmed C/T: 100.0%
Duration med. (IQR): CF = 18.5 (14–37.5) days, non-CF = 15.0 (10–25) days
Clinical failure: 54.3
(19/35)
- -
2018 studies        
Peer-reviewed literature        
 Diaz-Cañestro et al. 2018 [30]
Prospective,
single center
Spain
58 PsA (86.2% XDR) infections, including RTIs (60.3%), UTIs (17.2%), and IAIs (6.9%) ICU N = 16
IMC N = 7
CCI med. = 4
SOFA med. = 3
Dose C/T: 1.5 g q8h (46.6%), 3 g q8h (41.4%), 0.75 g q8h (12.1%)
Empiric C/T: 1.7%
Confirmed C/T: 91.4%
Duration mean (SD): 11.4 (6.2) days
63.8
(37/58)
- 27.6
(16/58)
 Dietl et al. 2018 [31] Retrospective, single center, case series
Spain
7 XDR PsA SSTIs (43%) and osteomyelitis (57%) CCI med. = 6 Dose C/T: 1.5 g q8h (43%), 0.75 g q8h (29%), 0.375 g q8h (29%)
Empiric C/T: 0%
Confirmed C/T: 71%
Duration med. (range): SSTI 13 (4–27)/ osteo. 48 (21–66) days
86
(6/7)
100
(4/4)
0
 Escolà-Vergé et al. 2018 [32]
Retrospective, single center
Spain
38 XDR PsA infections, including RTIs (36.8%), SSTIs (15.8%), and UTIs (15.8%) ICU N = 12
CCI med. = 3.5
Dose C/T: 3 g q8h (60.5%), 1.5 g q8h (39.5%)
Duration med. (range): 15.5 (3–62) days
68.4
(26/38)
Micro. recur.:
31.6
(12/38)
13.2
(5/38)
 Gallagher et al. 2018 [33]
Retrospective, multicenter
US
205 MDR PsA infections, including 59% pneumonia, UTI (13.7%), and wound (12.7%) ICU N = 105
APACHE II med. = 19
CCI med. = 4
Dose C/T: 3 g q8h (47.3%), 1.5 g q8h (52.7%)
Duration med. (IQR): 10 (7–14) days
73.7
(151/205)
70.7
(145/205)
19.0
(39/205)
 Hakki et al. 2018 [34]
Retrospective, single center, case series
US
6 7 episodes of MDR PsA infections, including bacteremia (42.9%), pneumonia (42.9%), and soft tissue (14.3%) in patients with hematological malignancy or hematopoietic stem cell transplant IMC N = 6 Dose C/T: 3 g q8h (100%)
Empiric C/T: 33.3%
Confirmed C/T: 66.7%
Duration med. (range): 29 (14–103) days
71.4
(5/7)b
- 0
 Xipell et al. 2018 [35]
Retrospective, single center, case series
Spain
23 24 episodes of MDR PsA infections, including RTI (33.3%), UTI (29.2%). and SSTI (25.0%) ICU N = 4 Dose C/T: 3 g q8h or 1.25 g q8h or 0.75 g q8h (% = NR)
Empiric C/T: 13%
Confirmed C/T: 87%
Duration mean (SD): 14.3 (9.4) days
88
(21/24)
75
(12/16)
22
(5/23)
Conference proceedings        
 Elabor et al. 2018 [97]
Retrospective, multicenter
US
65 MDR PsA infections, including pneumonia, wound/bone/joint infections, UTIs, and IAIs (% NR) in immunocompromised patients ICU N = 37
IMC N = 65
APACHE II med. = 20
CCI med. = 6
Dose C/T: 3 g q8h (35.4%), 1.5 g q8h (35.4%), < 1.5 g q8h (29.2%) 78.4
(51/65)
75.3
(NR)
13.9
(9/65)
 Gioia et al. 2018 [96]
Retrospective, single center
Spain
15 MDR PsA infections, including RTI (53%), IAI (27%), and wound (13%) ICU N = 8
IMC N = 9
CCI med. = 4
Dose C/T: 1.5 g q8h (67%), < 1.5 g q8h (13%), 3 g q8h (20%)
Duration med. (range): 23 (2–102) days
60
(9/15)
60
(9/15)
27
(4/15)
 Henry et al. 2018 [95]
Retrospective, single center
US
29 42 treatment courses for gram-negative infections (86% PsA; 7% Klebsiella spp.; 7% E. coli), including pneumonia (26%), IAIs (21%), and UTI (21%) ICU N = 15 Dose C/T: med. (range) = 1.5 g (0.15–3 g) q8h
Empiric C/T: 36%
Confirmed C/T: 64%
Duration med. (range): 10 (2–85) days
76
(32/42)
- 38
(11/29)
 Hirsch et al. 2018 [94]
Retrospective, multicenter
US
35 Gram-negative infections (79% PsA: 60.7% MDR; 21.4% XDR), including RTIs (33%), BSIs (21%), and bone/joint infections (18%) ICU N = 26 Dose C/T: 3 g q8h (42.9%), 1.5 g q8h (31.4%), 0.75 g q8h (17.1%), 0.375 g q8h (2.9%), Other (5.7%)
Empiric C/T: 20%
Confirmed C/T: 80%
77.4
(24/31)
74.2
(23/31)
14.3
(5/35)
 Jayakumar et al. 2018 [92]
Retrospective, single center
US
22 PsA (95%; 90% MDR) sepsis and/or bacteremia infections - Dose C/T: 3 g q8h (55%), Other (45%)
Empiric C/T: 18%
Confirmed C/T: 82%
Duration med.: 10 days
77
(17/22)
- 23
(5/22)
 Jorgensen et al. 2018 [90]
Retrospective, multicenter
US
116 MDR PsA infections, including RTI (65%), UTI (10.3%), and SSTI (9.4%) ICU N = 72
IMC N = 22
APACHE II med. = 21
CCI med. = 3.5
- Clinical failure:
38.8 (45/116)
- 17.2
(20/116)
 Jorgensen et al. 2018 [91]
Retrospective, multicenter
US
137 MDR PsA infections ICU N = 87
IMC N = 11
- - - 18.2
(25/137)
 Pogue et al. 2018 [89]
Retrospective, multicenter
US
113 PsA cUTI (64%) and cIAI (36%) - Empiric C/T: 31%
Confirmed C/T: early definite 28% and late definite 41%
- - 12.4
(14/113)
 Puzniak et al. 2018 [87]
Retrospective, multicenter
US
1,490 Gram-negative infections (78% PsA [202/259 patients with microbiological results]) ICU N = 824
CCI mean = 3
- - - 9.1
(NR)
 Puzniak et al. 2018 [88]c
Retrospective, multicenter
US
199 PsA infections, including RTIs (57%) and UTIs (17%) ICU N = 107
CCI mean = 2.9
Empiric C/T: 34%
Confirmed C/T: early direct 50% and late direct 16%
Duration med. (IQR): 8 (4–13) days
- - 14
(28/199)
 Tordato et al. 2018 [86]
Retrospective, single center
Italy
11 PsA infections (73% XDR), including RTIs (54%), BSIs (27%), and IAIs (18%) ICU N = 6
IMC N = 3
CCI med. = 4
Duration med. (range): 16 (6–27) days 100.0
(11/11)
- 36.4d
(4/11)
2017 studies        
Peer-reviewed literature        
 Álvarez Lerma et al. 2017 [36]
Retrospective, single center, case series
Spain
2 PDR PsA ventilation-associated respiratory infections ICU N = 2
APACHE II mean = 25.5
Dose C/T: 1.5 g q8h then 0.75 g q8h (50%), 0.75 g q8h (50%)
Empiric C/T: 0%
Confirmed C/T: 100%
Duration: mean = 15.5 days
100
(2/2)
100
(2/2)
50
(1/2)
 Castón et al. 2017 [37]
Retrospective, multicenter,
case series
Spain
12 MDR PsA infections, including RTIs (50%) and IAIs (25.0%). 83% of patients had septic shock IMC N = 4 Dose C/T: 1.5 g q8h (67%), 3 g q8h (33%)
Empiric C/T: 0%
Confirmed C/T: 100%
Duration med. (range): 12 (9–18) days
75.0
(9/12)
63.6
(7/11)
25.0
(3/12)
 Dinh et al. 2017 [38]
Retrospective, multicenter,
case series
France
15 XDR PsA infections, including RTIs (46.7%), UTIs (20.0%), and IAIs (13.3%) ICU N = 8
IMC N = 10
SOFA mean = 7.6
Dose C/T: med. (range) = 6 g (3–7.5 g)
Duration med. (range): 15 (4–63) days
67
(10/15)
75
(6/8)
27
(4/15)
 Haidar et al. 2017 [39]
Retrospective, single center, case series
US
21 MDR PsA infections, including 86% RTIs, 5% cUTIs, 5% cIAIs, and 5% bacteremia IMC N = 9
CCI med. = 5
SOFA med. = 6
Dose C/T: 1.5 g q8h (48%), 0.75 g q8h (24%), 0.375 g q8h (5%), Other (23%)
Duration med. (range): 14 (3–52) days
Clinical failure:
29
(6/21)
- 10
(2/21)
 Munita et al. 2017 [40]
Retrospective, multicenter
US
35 CR PsA infections, including pneumonia (51.0%) and secondary BSI (17.1%) CCI med. = 4 Dose C/T: 3 g q8h (26%), 0.375–1.25 g q8h (% = NR)
Duration med. (range): 16 (5–27) days
74
(26/35)
100
(25/25)
22.8
(8/35)
 Sacha et al. 2017 [41]
Retrospective, single center
US
49 60 courses of therapy for gram-negative infections (86.7% PsA: 34.6% non-MDR; 40.4% MDR; 25.0% XDR), including NP (56.7%), IAI (18.3%), and bacteremia (6.7%) ICU N = 37
IMC N = 25
Dose C/T: 3 g q8h (1.7%), 1.5 g q8h (51.7%), 0.75 g q8h (26.7%), 0.375 g q8h (8.3%), 0.15 g q8h (11.7%)
Empiric C/T: 36.7%
Confirmed C/T: 63.3%
Duration med.: 1–8 dayse
64.1f
(25/39)
38.5
(5/13)
16.7
(10/60)
 Xipell et al. 2017 [42]
Retrospective, single center, case series
Spain
3 MDR or XDR PsA infections, including mediastinitis, liver abscess, and septic shock - Dose C/T: 1.5 g q8h (100%)
Empiric C/T: 0%
Confirmed C/T: 100%
Duration mean (range): 30.3 (21–42) days
100
(3/3)
- 0
Conference proceedings        
 Leuthner et al. 2017 [98]
Retrospective, single center
US
30 Gram-negative infections (93% PsA; 3% E. coli; 3% P. stuartii), including RTIs (67%), cUTIs (27%), and BSIs (20%) ICU N = 8
IMC N = 4
Dose C/T: 3 g q8h (57%), Other (43%)
Empiric C/T: 23%
Confirmed C/T: 77%
Duration med.: 10 days
80
(24/30)
92
(11/12)
20
(6/30)
2016 studies        
Conference proceedings        
 Iovleva et al. 2016 [100]
Retrospective, single center, case series
US
2 Imipenem-resistant PsA HCAP APACHE II mean = 13
CCI mean = 2
- 100
(2/2)
100
(2/2)
0
 Nathan et al. 2016 [99]
Retrospective, multicenter
US
28 Gram-negative infections (68% resistant pathogens, including 36.4% MDR PsA and 15.2% ESBL-producing E. coli), including RTI (28.6%), cIAI (25%), and cUTI (25%) ICU N = 0 Duration: med. = 12 days for RTI, 12 days for cIAI and 15 days for cUTI 89
(24/27)
- -
2015 studies        
Peer-reviewed literature        
 Gelfand et al. 2015 [43]
Retrospective, single center, case series
US
3 MDR PsA pneumonia IMC = 2 Dose C/T: 3 g q8h (100%)
Duration mean (range): 12.7 (10–14) days
100
(3/3)
100
(3/3)
0
  1. a2 patients died—both completed therapy and were in the clinical cure group, but later succumbed to comorbid conditions
  2. b2 of the 7 courses were considered clinical failures. One patient with clinical failure then had a successful C/T course
  3. cThis study contains a subset of patients identified in Puzniak et al. 2018 [87]
  4. dAlthough all patients had a favorable clinical outcome, 4 patients were reported to have died from other causes
  5. eMedian duration of therapy in patients who received pathogen-directed therapy was 8 days; empiric-turned-pathogen-directed therapy, 8 days; empiric-remained-empiric therapy, 7.5 days; and empiric therapy that was subsequently changed or discontinued, 1 day
  6. fOnly assessed in patients with C/T-susceptible infections
  7. ABSSSI: Acute bacterial skin and skin structure infection; APACHE: Acute Physiology and Chronic Health Evaluation; BSI: Bloodstream infection; CCI: Charlson Comorbidity index; CI: Continuous infusion; cIAI: Complicated intra-abdominal infection; CF: Cystic fibrosis; CLABSI: Central-line-associated bloodstream infection; CR: Carbapenem-resistant; cSSTI: Complicated skin and soft tissue infection; C/T: Ceftolozane/tazobactam; cUTI: Complicated urinary tract infection; ESBL: Extended-spectrum β-lactamase; HABP: Hospital-acquired bacterial pneumonia; HCAP: Healthcare-associated pneumonia; IAI: Intra-abdominal infection; ICU: Intensive care unit; IMC: Immunocompromised; IQR: Interquartile range; LVAD: Left-ventricular assist device; MDR: Multidrug-resistant; NP: Nosocomial pneumonia; NR: Not reported; PDR: Pandrug-resistant; PsA: Pseudomonas aeruginosa; RTI: Respiratory tract infection; SD: Standard deviation; SOFA: Sequential Organ Failure Assessment; SSTI: Skin and soft tissue infection; US: United States; UTI: Urinary tract infection; VABP: Ventilator-associated bacterial pneumonia; XDR: Extensively-drug-resistant