Background
Methods
Search strategy
Article selection
Data extraction
Study quality assessment
Statistical analysis
Results
Selection of the studies
Characteristics of the selected studies
First Author | Title | Publication year | Type of study | Country | Study period |
---|---|---|---|---|---|
Jandourek et al. [9] | Efficacy of ceftaroline fosamil for bacteremia associated with community-acquired bacterial pneumonia | 2014 | Clinical Trial | USA | Jul 2007-Dec 2008 |
File et al. [10] | FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia | 2011 | Clinical Trial | USA | Jan 2008-Dec 2008 |
Low et al. [11] | FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia | 2011 | Clinical Trial | USA | Jul 2007-Aug 2008 |
Shorr et al. [12] | Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials | 2013 | Clinical Trial | USA | Jul 2007-Dec 2008 |
File et al. [13] | Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus. Ceftriaxone in patients with community-acquired pneumonia | 2010 | Clinical Trial | USA | Jul 2007-Dec 2008 |
Zhong et al. [14] | Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial | 2015 | Clinical Trial | China, India, South Korea, Taiwan, Vietnam | Dec 2011-Apr 2013 |
Arshad et al. [15] | Ceftaroline fosamil for treatment of Methicillin-Resistant Staphylococcus aureus hospital-acquired pneumonia and health care-associated pneumonia. A 5-year matched case-control evaluation of epidemiology and outcomes | 2016 | Case-control study | USA | Jan 2009-May 2013 |
Eckburg et al. [22] | Day 4 Clinical response of ceftaroline fosamil versus ceftriaxone for community-acquired bacterial pneumonia | 2012 | Retrospective integrated analysis of FOCUS trials | USA | Jul 2007-Dec 2008 |
Guervil et al. [16] | Ceftaroline fosamil as first-line versus second-line treatment for acute bacterial skin and skin structure infections (ABSSSI) or community-acquired bacterial pneumonia (CABP) | 2015 | Retrospective Cohort study | USA | Aug 2011-Feb 2013 |
Udeani et al... [17] | Ceftaroline fosamil for the treatment of community-acquired bacterial pneumonia in elderly patients | 2014 | Retrospective Cohort study | USA | Aug 2011-Ap 2013 |
Ramani et al..... [18] | Contemporary use of ceftaroline fosamil for the treatment of community-acquired bacterial pneumonia: CAPTURE study experienc | 2014 | Retrospective Cohort study | USA | Aug 2011-Feb 2013 |
Vasquez et al... [19] | Ceftaroline Fosamil for the Treatment of Staphylococcus aureus Bacteremia Secondary to Acute Bacterial Skin and Skin Structure Infections or Community-Acquired Bacterial Pneumonia | 2015 | Retrospective Cohort study | USA | Aug 2011-Feb 2013 |
Casapao et al... [20] | Large retrospective study evaluation of the effectiveness and safety of Ceftaroline fosamil therapy | 2014 | Retrospective observational study | USA | Jan 2011-Jun 2013 |
Kaye et al. [21] | Ceftaroline fosamil for the treatment of hospital acquired pneumonia and ventilator associated pneumonia | 2015 | Retrospective Cohort study | USA | Sep 2013-Mar 2014 |
Characteristics of the enrolled cohort compared with a control group
Study | Sample size, n | Sample size, n | Mean (SD) age, y | Male, n (%) | Ethnic origina, n (%) | ||||
---|---|---|---|---|---|---|---|---|---|
Ceftaroline group | Control group | Ceftaroline group | Control group | Ceftaroline group | Control group | Ceftaroline group | Control group | ||
45 | 23 | 22 | 60.6 (16.1) | 63.2 (16.2) | 15 (65.2) | 17 (77.3) | – | – | |
591 | 291 | 300 | 61.0 (16.6) | 61.2 (16.4) | 187 (64.3) | 191 (63.7) | 260 (89.3) | 268 (83.3) | |
562 | 289 | 273 | 60.6 (16.1) | 62.0 (14.7) | 175 (60.6) | 175 (64.1) | 278 (96.2) | 264 (96.7) | |
139 | 69 | 70 | 63 (17) | 62 (15) | 43 (62.3) | 47 (67.1) | – | – | |
1153 | 580 | 573 | 60.8 (16.4) | 61.6 (15.6) | 362 (62.4) | 366 (63.9) | 538 (92.8) | 532 (92.8) | |
763 | 381 | 382 | 66.1 (14.7) | 65.8 (13.9) | 265 (69.6) | 272 (71.2) | 381 (100.0) A | 382 (100.0) A | |
149 | 40 | 109 | 58.8 (16.1) | 58.8 (16.4) | 20 (50.0) | 54 (49.5) | 16 (40.0) B | 46 (42.2) B | |
309 | 154 | 155 | 59.9 (17.7) | 60.5 (16.0) | 99 (64.3) | 97 (62.6) | – | – |
Study | Ceftaroline group | Control group | Ceftaroline group | Control group | Ceftaroline group | Control group | Ceftaroline group | Control group | Ceftaroline group | Control group |
---|---|---|---|---|---|---|---|---|---|---|
PSI risk class III, n (%) | PSI risk class IV, n (%) | Severe CAPa, n (%) | Multilobar infiltrate, n (%) | Pleural effusion, n (%) | ||||||
5 (21.7) | 5 (22.7) | 18 (78.3) | 15 (68.2) | – | – | 5 (21.7) | 5 (22.7) | 5 (21.7) | 5 (22.7) | |
190 (65.3) | 182 (60.7) | 101 (34.7) | 118 (39.3) | 82 (28.2) | 89 (29.7) | – | – | – | – | |
170 (58.8) | 171 (62.6) | 119 (41.2) | 102 (37.4) | 99 (34.3) | 80 (29.3) | – | – | – | – | |
34 (49.3) | 37 (52.9) | 35 (50.7) | 33 (47.1) | 22 (31.9) | 32 (45.7) | 18 (26.1) | 21 (30.0) | 15 (21.7) | 13 (18.6) | |
360 (62.1) | 353 (61.6) | 220 (37.9) | 220 (38.4) | – | – | – | – | – | – | |
255 (67.0) | 265(69.4) | 126 (33.1) | 117 (30.6) | – | – | – | – | – | – | |
– | – | – | – | – | – | – | – | – | – | |
84 (54.5) | 82 (52.9) | 61 (39.6) | 61 (39.4) | – | – | – | – | – | – | |
Structural lung diseaseb, n (%) | Prior pneumonia, n (%) | Asthma, n (%) | Prior antimicrobial therapy, n (%) | Bacteremia, n (%) | ||||||
– | – | – | – | – | – | – | – | 23 (100.0) | 22 (100.0) | |
64 (22.0) | 60 (20.0) | 61 (21.0) | 51 (17.0) | 25 (8.6) | 25 (8.3) | 137 (47.1) | 143 (47.7) | 8 (2.7) | 9 (3.0) | |
96 (33.2) | 87 (31.9) | 62 (21.5) | 41 (15.0) | 24 (8.3) | 13 (4.8) | 100 (34.6) | 117 (42.9) | 15 (5.2) | 11 (4.0) | |
– | – | – | – | – | – | 26 (37.7) | 32 (45.7) | 19 (27.5) | 13 (18.6) | |
160 (27.6) | 147 (25.7) | 123 (21.2) | 92 (16.1) | 49 (8.4) | 38 (6.6) | – | – | 23 (4.0) | 20 (3.5) | |
120 (31.5)c | 121 (31.7)c | – | – | 21 (5.5) | 22 (5.8) | 80 (21.0) | 85 (22.3) | 3 (0.8) | 5 (1.3) | |
8 (20.0) | 31 (28.4) | – | – | – | – | 4 (11.8) | 24 (23.3) | – | – | |
43 (27.9) | 41 (26.5) | – | – | – | – | 57 (37.0) | 68 (43.9) | 23 (14.9) | 21 (13.5) | |
Diabetes mellitus, n (%) | ||||||||||
Jandourek et al, 2014 | – | – | ||||||||
File et al, 2011 | – | – | ||||||||
Low et al, 2011 | – | – | ||||||||
Shorr et al, 2013 | – | – | ||||||||
File et al, 2010 | – | – | ||||||||
Zhong et al, 2015 | 62 (16.3) | 62 (16.3) | ||||||||
Arshad et al., 2016 | 10 (25.0) | 20 (18.4) | ||||||||
Eckburg et al..., 2012 | – | – |
Characteristics of the enrolled cohort without a control group
Study | Sample size, n | Mean (SD) age, y | Male, n (%) |
---|---|---|---|
396 | 64.3 (1.7) | 198 (50.0) | |
528 | 63.6 (20.2) | 255 (48.3) | |
398 | 63.5 (17.8) | 199 (50.0) | |
21 | 60 (18) | 11 (52.4) | |
92 | – | – | |
40 | 61.3 (16.8) | 23 (57.5) |
Study | Structural lung diseasea, n (%) | Congestive heart failure, n (%) | Prior pneumonia, n (%) | GERD, n (%) | Smoking, n (%) | Prior antimicrobial therapy, n (%) |
---|---|---|---|---|---|---|
161 (40.7) | 79 (20.0) | 98 (24.8) | 91 (23.0) | 114 (28.8) | 396 (100.0) | |
228 (43.2) | 113 (21.4) | 134 (25.4) | 127 (24.1) | 159 (30.1) | – | |
162 (40.7) | 80 (20.1) | 98 (24.6) | 92 (23.1) | 114 (28.6) | 328 (82.4) | |
– | – | – | – | – | 18 (85.7) | |
– | – | – | – | – | – | |
19 (47.5) | 8 (0.20) | 10 (25.0) | 10 (25.0) | 21 (52.5) | – |
Efficacy and effectiveness of ceftaroline fosamil
Safety and tolerability of ceftaroline fosamil
Study | Ceftaroline group | Control group | Ceftaroline group | Control group | Ceftaroline group | Control group | Ceftaroline group | Control group |
---|---|---|---|---|---|---|---|---|
Any adverse events, n (%) | Diarrhea, n (%) | Headache, n (%) | Insomnia, n (%) | |||||
119/298 (39.9) | 136/308 (44.2) | 14/298 (4.7) | 7/308 (2.3) | 10/298 (3.4) | 4/308 (1.3) | 9/298 (3.0) | 6/308 (1.9) | |
196/315 (53.7) | 145/307 (47.2) | 12/315 (3.8) | 9/307 (2.9) | 11/315 (3.5) | 5/307 (1.6) | 10/315 (3.2) | 8/307 (2.6) | |
288/613 (47.0) | 281/615 (45.7) | 26/613 (4.2) | 16/615 (2.6) | 21 /613 (3.4) | 9/615 (1.5) | 19/613 (3.1) | 14/615 (2.3) | |
172/381 (45.1) | 163/383 (42.7) | 24/381 (6.3) | 13/383 (3.4) | 6/381 (1.6) | 9/383 (2.4) | – | – | |
Nausea, n (%) | Phlebitis, n (%) | Hypertension, n (%) | Hypokalaemia, n (%) | |||||
8/298 (2.7) | 8/308 (2.6) | 7/298 (2.3) | 5/308 (1.6) | 6/298 (2.0) | 8/308 (2.6) | 4/298 (1.3) | 10/308 (3.2) | |
6/315 (1.9) | 6/307 (2.0) | 10/315 (3.2) | 8/307 (2.6) | 8/315 (2.5) | 8/307 (2.6) | 10/315 (3.2) | 5/307 (1.6) | |
14/613 (2.3) | 14/615 (2.3) | 17/613 (2.8) | 13/615 (2.1) | 14/613 (2.3) | 16/615 (2.6) | 14/613 (2.3) | 15/615 (2.4) | |
8/381 (2.1) | 3/383 (0.8) | – | – | – | – | 5/381 (1.3) | 4/383 (1.1) |
Study | Mortality rate, n (%) | |
---|---|---|
Ceftaroline group | Control group | |
Jandourek et al, 2014 | – | – |
File et al, 2011 | 6/298 (2.0) | 6/308 (1.9) |
Low et al, 2011 | 9/315 (2.9) | 6/307 (2.0) |
Shorr et al, 2013 | – | 1/70 (1.4) |
File et al, 2010 | 15/613 (2.4) | 12/615 (2.0) |
Zhong et al, 2015 | 3/381 (0.8) | 4/383 (1.0) |
Arshad et al, 2016 28-day mortality | 4/40 (10.0)a | 16/109 (14.7)a |
Eckburg et al, 2012 | – | – |
Ramani et al, 2014 | 8/398 (2.0)b | – |
Casapao et al, 2014 | 13/92 (14.1)b | – |
Vasquez et al, 2015 | 1/21 (4.8) | – |
Guervil et al, 2015 | 8/396 (2.0)b | – |
Kaye et al, 2015 | 5/40 (12.5) | – |
Udeani et al, 2014 | 15/528 (2.8) | – |