TABLE 1.
Baseline demographics and clinical characteristicsc
| Characteristic | SmMITT population |
mMITT population |
||||
|---|---|---|---|---|---|---|
| IMI-REL (n = 28) | Colistin plus IMI (n = 13) | Total (n = 41) | IMI-REL (n = 21) | Colistin plus IMI (n = 10) | Total (n = 31) | |
| No. of patients in population | 28 | 13 | 41 | 21 | 10 | 31 |
| No. of patients by sex | ||||||
| Male | 18 (64.3) | 10 (76.9) | 28 (68.3) | 13 (61.9) | 7 (70.0) | 20 (64.5) |
| Female | 10 (35.7) | 3 (23.1) | 13 (31.7) | 8 (38.1) | 3 (30.0) | 11 (35.5) |
| No. of patients by age (yr) | ||||||
| <65 | 16 (57.1) | 6 (46.2) | 22 (53.7) | 15 (71.4) | 5 (50.0) | 20 (64.5) |
| ≥65 | 12 (42.9) | 7 (53.8) | 19 (46.3) | 6 (28.6) | 5 (50.0) | 11 (35.5) |
| Median (range) age (yr) | 61 (19–77) | 65 (49–80) | 63 (19–80) | 59 (19–75) | 61 (49–80) | 59 (19–80) |
| Median (range) wt (kg) | 79.3 (53.0–140.0) | 75.8 (52.8–117.0) | 78.0 (52.8–140.0) | 75 (53.0–132.3) | 75.6 (52.8–117.0) | 75 (52.8–132.3) |
| No. of patients with the following APACHE II score: | ||||||
| ≤15 | 20 (71.4) | 11 (84.6) | 31 (75.6) | 14 (66.7) | 8 (80.0) | 22 (71.0) |
| >15 | 8 (28.6) | 2 (15.4) | 10 (24.4) | 7 (33.3) | 2 (20.0) | 9 (29.0) |
| No. of patients with the following primary diagnosis: | ||||||
| HABP | 1 (3.6) | 1 (7.7) | 2 (4.9) | 1 (4.8) | 1 (10.0) | 2 (6.5) |
| VABP | 7 (25.0) | 3 (23.1) | 10 (24.4) | 7 (33.3) | 2 (20.0) | 9 (29.0) |
| cIAI | 5 (17.9) | 3 (23.1) | 8 (19.5) | 2 (9.5) | 2 (20.0) | 4 (12.9) |
| cUTI (urinary tract abnormalities) | 8 (28.6) | 3 (23.1) | 11 (26.8) | 5 (23.8) | 3 (30.0) | 8 (25.8) |
| cUTI (acute pyelonephritis) | 7 (25.0) | 3 (23.1) | 10 (24.4) | 6 (28.6) | 2 (20.0) | 8 (25.8) |
| No. of patients with the following creatinine clearance (ml/min): | ||||||
| ≥90 | 8 (28.6) | 5 (38.5) | 13 (31.7) | 8 (38.1) | 3 (30.0) | 11 (35.5) |
| <90 to ≥60 | 14 (50.0) | 4 (30.8) | 18 (43.9) | 8 (38.1) | 4 (40.0) | 12 (38.7) |
| <60 to ≥30 | 4 (14.3) | 3 (23.1) | 7 (17.1) | 3 (14.3) | 2 (20.0) | 5 (16.1) |
| <30 to ≥15 | 1 (3.6) | 1 (7.7) | 2 (4.9) | 1 (4.8) | 1 (10.0) | 2 (6.5) |
| Not available | 1 (3.6) | 0 | 1 (2.4) | 1 (4.8) | 0 | 1 (3.2) |
| No. of patients with the following qualifying baseline pathogens: | ||||||
| Citrobacter freundii | 1 (3.4) | 0 (0.0) | 1 (2.4) | 1 (4.8) | 0 | 1 (3.2) |
| Enterobacter aerogenes | 0 | 1 (7.7) | 1 (2.4) | 0 | 0 | 0 |
| Enterobacter cloacae | 2 (6.9) | 1 (7.7) | 3 (7.1) | 1 (4.8) | 0 | 1 (3.2) |
| Escherichia coli | 1 (3.4) | 0 | 1 (2.4) | 0 | 0 | 0 |
| Klebsiella oxytoca | 0 | 1 (7.7) | 1 (2.4) | 0 | 1 (10.0) | 1 (3.2) |
| Klebsiella pneumoniae | 6 (20.7) | 2 (15.4) | 8 (19.0) | 3 (14.3) | 1 (10.0) | 4 (12.9) |
| Pseudomonas aeruginosa | 19 (65.5) | 8 (61.5) | 27 (64.3) | 16 (76.2) | 8 (80.0) | 24 (77.4) |
| No. of patients with isolates with the following β-lactamasesa : | ||||||
| Class A | ||||||
| Older-spectrum β-lactamases | ||||||
| SHVb | 4 (14.3) | 2 (15.4) | 6 (14.6) | 2 (9.5) | 1 (10.0) | 3 (9.7) |
| TEM | 12 (42.9) | 3 (23.1) | 15 (36.6) | 7 (33.3) | 3 (30.0) | 10 (32.3) |
| ESBLs | ||||||
| CTX-M | 12 (42.9) | 6 (46.2) | 18 (43.9) | 7 (33.3) | 4 (40.0) | 11 (35.5) |
| SHVb | 2 (7.1) | 0 | 2 (4.9) | 1 (4.8) | 0 | 1 (3.2) |
| VEB | 0 | 0 | 0 | 0 | 0 | 0 |
| KPC serine carbapenemase | 5 (17.9) | 1 (7.7) | 6 (14.6) | 4 (19.0) | 1 (10.0) | 5 (16.1) |
| Class C | ||||||
| Chromosomal AmpC (PDC) | 19 (67.9) | 8 (61.5) | 27 (65.9) | 16 (76.2) | 8 (80.0) | 24 (77.4) |
| Plasmid-mediated AmpC | ||||||
| ACT | 0 | 0 | 0 | 0 | 0 | 0 |
| CMY | 1 (3.6) | 0 | 1 (2.4) | 1 (4.8) | 0 | 1 (3.2) |
| DHA | 1 (3.6) | 0 | 1 (2.4) | 1 (4.8) | 0 | 1 (3.2) |
| Class D, OXA-48 | 4 (14.3) | 2 (15.4) | 6 (14.6) | 0 | 1 (10.0) | 1 (3.2) |
a
Qualifying baseline pathogens could have had multiple β-lactamases detected.
b
Older-spectrum β-lactamases were SHV-1 and SHV-11; ESBLs were SHV-26 and SHV-28.
c
APACHE II, Acute Physiologic Assessment and Chronic Health Evaluation II; cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; ESBL, extended-spectrum β-lactamase; HABP, hospital-acquired bacterial pneumonia; IMI, imipenem-cilastatin; mMITT, microbiological modified intent-to-treat; REL, relebactam; SmMITT, supplemental microbiological modified intent-to-treat; VABP, ventilator-associated bacterial pneumonia.