TABLE 2.
Central versus local MICs of qualifying baseline pathogens for patients included in the SmMITT population but excluded from the mMITT populationb
| Patient no. | TG | Infection type | Qualifying pathogen name | Local interpretive criteria used | MIC (μg/ml [susceptibility])c
|
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| Imipenem |
IMI-REL |
Colistin |
||||||||
| Local lab | Central lab | Local lab | Central lab | Local lab | Central lab | |||||
| 1 | 2 | HABP/VABP | E. aerogenes | CLSI | 2 (I) | 1 (S) | 0.5 (S) | 0.12 (S) | 0.25 (S) | <1 (S) |
| 2a | 1 | cIAI | K. pneumoniae | EUCAST | 8 (I) | 4 (I) | 2 (S) | 2 (S) | 2 (S) | 4 (R) |
| 3 | 2 | cIAI | E. cloacae | CLSI | 2 (I) | <0.5 (S) | 0.5 (S) | 0.12 (S) | 1 (S) | <1 (S) |
| 4 | 1 | cIAI | E. cloacae | CLSI | 2 (I) | <0.5 (S) | 1 (S) | 0.12 (S) | 1 (S) | <1 (S) |
| 5 | 1 | cIAI | K. pneumoniae | CLSI | 4 (R) | 4 (R) | 1 (S) | 2 (I) | 0.5 (S) | <1 (S) |
| 6 | 1 | cUTI | E. coli | CLSI | 2 (I) | 2 (I) | 1 (S) | 2 (I) | 0.12 (S) | <1 (S) |
| 7 | 2 | cUTI | K. pneumoniae | CLSI | 2 (I) | 2 (I) | 1 (S) | 2 (I) | 0.12 (S) | <1 (S) |
| 8 | 1 | cUTI | K. pneumoniae | CLSI | 16 (R) | 32 (R) | 1 (S) | 2 (I) | 0.25 (S) | <1 (S) |
| 9 | 1 | cUTI | P. aeruginosa | CLSI | 8 (R) | 2 (S) | 2 (S) | 0.5 (S) | 1 (S) | <1 (S) |
| 10 | 1 | cUTI | P. aeruginosa | CLSI | 16 (R) | 2 (S) | 1 (S) | 0.25 (S) | 0.12 (S) | <1 (S) |
The participant had a polymicrobial infection, including an infection caused by a qualifying P. aeruginosa isolate, but was unevaluable for the mMITT population due to the presence of colistin-nonsusceptible K. pneumoniae.
cIAI, complicated intra-abdominal infection; CLSI, Clinical and Laboratory Standards Institute; cUTI, complicated urinary tract infection; EUCAST, European Committee on Antimicrobial Susceptibility Testing; HABP, hospital-acquired bacterial pneumonia; I, intermediate; IMI-REL, imipenem-cilastatin plus relebactam; mMITT, microbiological modified intent-to-treat; R, resistant; S, susceptible; SmMITT, supplemental microbiological modified intent-to-treat; TG, treatment group; VABP, ventilator-associated bacterial pneumonia.
Data in boldface indicate differences in susceptibility test interpretation (susceptible versus intermediate versus resistant) between the local laboratory and central laboratory, based on MIC values.