Chinese Medical Sciences Journal ›› 2021, Vol. 36 ›› Issue (1): 1-16.doi: 10.24920/003864
• Guideline & Consensus • Next Articles
Expert Consensus on Polymyxin Antimicrobial Susceptibility Testing and Clinical Interpretation
Qiwen Yang1, Xiaoling Ma2, Fupin Hu3, Jing Zhang3, Tongwen Sun4, Baiyi Chen5, Yingchun Xu1, *(
), Youning Liu6, *(), China Medical Education Association , Expert Committee on Infectious Diseases, China Medical Education Association
- 1Department of Clinical Laboratory, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
2Department of Laboratory Medicine, the First Affiliated Hospital, University of Science and Technology of China, Hefei 230001, China
3Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, China
4General ICU, the First Affiliated Hospital, Zhengzhou University, Zhengzhou 450052, China
5Department of Infectious Diseases, the First Affiliated Hospital, China Medical University, Shenyang 110001, China
6Department of Respiratory Medicine, the First Medical Center of PLA General Hospital, Beijing 100853, China
-
Received:2020-12-10Accepted:2020-12-14Published:2021-01-14Online:2021-01-14 -
Contact:Yingchun Xu,Youning Liu E-mail:xycpumch@139.com;liuyn301@126.com
| To address the inconsistence of international polymyxin clinical breakpoints, experts from Chinese Committee on Antimicrobial Susceptibility Testing and Expert Committee on Infectious Diseases China Medical Education Association were convened to formulate this consensus statement on the testing and clinical interpretation of polymyxin susceptibility. Relevant recommendations are proposed accordingly for laboratorians and clinicians to streamline their daily work. |
Cite this article
Qiwen Yang,Xiaoling Ma,Fupin Hu,Jing Zhang,Tongwen Sun,Baiyi Chen,Yingchun Xu,Youning Liu,China Medical Education Association ,Expert Committee on Infectious Diseases, China Medical Education Association . Expert Consensus on Polymyxin Antimicrobial Susceptibility Testing and Clinical Interpretation[J].Chinese Medical Sciences Journal, 2021, 36(1): 1-16.
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Table 1
Performance of different methods for testing polymyxin susceptibility"
| Testing method and organisms | Drug tested | Strains in terms of the indicated BMD-MIC values, n (%) | Performance evaluation (%) | |||||
|---|---|---|---|---|---|---|---|---|
| MIC ≤2 mg/L | MIC ≥4 mg/L | EA | CA | VME | ME | |||
| E-test | ||||||||
| Enterobacterales | Polymyxin B [ | 220 (95.7) | 10 (4.4) | 95.6 | 99.1 | 20.0 | 0 | |
| Enterobacterales | Polymyxin B [ | 53 (69.7) | 23 (30.3) | 48.7 | 89.5 | 26.1 | 1.9 | |
| Enterobacterales | Colistin [ | 51 (67.1) | 25 (32.9) | 75 | 92.1 | 12 | 5.9 | |
| Enterobacterales | Colistin [ | 219 (67.4) | 106 (32.6) | 80.6 | 96.3 | 9.4 | 0.9 | |
| E. coli | Colistin [ | 48 (90.6) | 5 (9.4) | 92.5 | 96.2 | 40.0 | 0 | |
| K. pneumoniae | Colistin [ | 126 (61.2) | 80 (38.8) | 79.8 | 99 | 1.6 | 2.5 | |
| E. cloacae | Colistin [ | 23 (59.0) | 16 (41.0) | 72.2 | 87.2 | 25.0 | 4.3 | |
| P. aeruginosa | Colistin [ | 78 (100) | 0 (0) | 79.5 | 93.6 | - | 6.4 | |
| A. baumannii | Colistin [ | 2 (10.0) | 18 (90.0) | 55.0 | 65.0 | 38.9 | 0 | |
| A. baumannii | Colistin [ | 42 (100) | 0 (0) | 11.9 | 100 | - | 0 | |
| A. baumannii | Polymyxin B [ | 42 (100) | 0 (0) | 85.7 | 100 | - | 0 | |
| Disk diffusion method | ||||||||
| Enterobacterales | IE | IE | IE | NA | IE | IE | IE | |
| P. aeruginosa | Colistin [ | 78 (100) | 0 (0) | NA | 100 | - | 0 | |
| A. baumannii | IE | IE | IE | NA | IE | IE | IE | |
| BD Phoenix | ||||||||
| Enterobacterales | Colistin [ | 219 (67.4) | 106 (32.6) | 76.1 | 92.0 | 24.5 | 0 | |
| E. coli | Colistin [ | 48 (90.6) | 5 (9.4) | - | 98.1 | 20.0 | 0 | |
| K. pneumoniae | Colistin [ | 126 (61.2) | 80 (38.8) | - | 96.1 | 10.0 | 0 | |
| E. cloacae | Colistin [ | 23 (59.0) | 16 (41.0) | - | 64.1 | 87.5 | 0 | |
| P. aeruginosa | IE | IE | IE | IE | IE | IE | IE | |
| A. baumannii | Colistin [ | 88 (75.2) | 29 (24.8) | 91.5 | 88.9 | 41.4 | 1.1 | |
| MicroScan | ||||||||
| Gram-negative bacteria | Colistin [ | 52 (28.1) | 133 (71.9) | IE | 91.9 | 0.8 | 26.9 | |
| Enterobacterales | Colistin [ | 44 (57.9) | 32 (42.1) | IE | 88.2 | 4.0 | 15.8 | |
| Enterobacterales | Colistin [ | 32 (21.9) | 114 (78.1) | IE | 99.3 | 0 | 3.1 | |
| Non-fermentative organism | Colistin [ | 20 (51.3) | 19 (48.7) | IE | 64.1 | 5.3 | 65.0 | |
| Vitek 2 | ||||||||
| Enterobacterales | Colistin [ | 60 (75.9) | 16 (24.1) | 93.4 | 88.2 | 36.0 | 0 | |
| Enterobacterales | Polymyxin B [ | 47 (61.8) | 29 (38.2) | 96.1 | 94.7 | 3.7 | 6.1 | |
| Enterobacterales | Colistin [ | 219 (67.4) | 106 (32.6) | 75.9 | 90.5 | 29.2 | 0 | |
| E. coli | Colistin [ | 48 (90.6) | 5 (9.4) | - | 94.3 | 60.0 | 0 | |
| K. pneumoniae | Colistin [ | 126 (61.2) | 80 (38.8) | 81.7 | 94.2 | 15.0 | 0 | |
| K. pneumoniae | Colistin [ | 1 (2.4) | 40 (97.6) | 75.6 | 100 | 0 | 0 | |
| E. cloacae | Colistin [ | 23 (59.0) | 16 (41.0) | - | 66.7 | 81.3 | 0 | |
| P. aeruginosa | IE | IE | IE | IE | IE | IE | IE | |
| A. baumannii | Colistin [ | 88 (75.2) | 29 (24.8) | 88.9 | 89.7 | 37.9 | 1.1 | |
| A. baumannii | Colistin [ | 42 (100) | 0 (0) | 26.2 | 100 | - | 0 | |
| A. baumannii | Polymyxin B [ | 42 (100) | 0 (0) | 57.1 | 100 | - | 0 | |
| Agar dilution method | ||||||||
| A. baumannii | Colistin [ | 88 (75.2) | 29 (24.8) | 93.2 | 87.2 | 3.4 | 15.9 | |
| A. baumannii | Colistin [ | 42 (100) | 0 (0) | 92.8 | 85.7 | - | 16.7 | |
| A. baumannii | Polymyxin B [ | 42 (100) | 0 (0) | 76.2 | 100 | - | 0 | |
| Colistin agar test | ||||||||
| Enterobacterales | Colistin [ | 152 (43.7) | 196 (56.3) | 99.7 | 99.7 | 0.5 | 0 | |
| P. aeruginosa | Colistin [ | 135 (91.2) | 13 (8.8) | 99.3 | 100 | 0 | 0 | |
| A. baumannii | Colistin [ | 60 (45.8) | 71 (54.2) | 88.5 | 92.3 | 14.3 | 0 | |
| Colistin broth disk elution | ||||||||
| Enterobacterales | Colistin [ | 152 (43.7) | 196 (56.3) | 94.3 | 98.6 | 2.5 | 0 | |
| P. aeruginosa | Colistin [ | 135 (91.2) | 13 (8.8) | 96.6 | 99.3 | 0 | 0.7 | |
| A. baumannii | Colistin [ | 60 (45.8) | 71 (54.2) | 93.1 | 95.4 | 5.6 | 3.3 | |
Table 1
Table 2
Breakpoints of polymyxin susceptibility testing recommended by international organizations [1-3, 13-14]"
| Species | CLSI 2019 (mg/L) | CLSI 2019 (mg/L) | CLSI 2020 (mg/L) | EUCAST 2020 (mg/L) | USCAST 2020 (mg/L)a | USFDA 2020 (mg/L) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Colistin | Polymyxin B | Colistin or polymyxin B | Colistin | Colistin or polymyxin B | Colistin or polymyxin B | |||||||||||||||
| S | I | R | S | I | R | I | R | S | R | ATU | S | R | I | R | ||||||
| Enterobac- terales | - | - | - | - | - | - | ≤2 | ≥4 | ≤2 | >2 | - | ≤2 | ≥4 | - | - | |||||
| P. aeruginosa | ≤2 | - | ≥4 | ≤2 | 4 | ≥8 | ≤2 | ≥4 | ≤2 | >2 | 4 | ≤2 | ≥4 | Reb | Reb | |||||
| A. baumannii | ≤2 | - | ≥4 | ≤2 | - | ≥4 | ≤2 | ≥4 | ≤2 | >2 | - | ≤2 | ≥4 | Nc | Nc | |||||
Table 2
Table 3
The epidemiological cutoff values of polymyxin for various bacterial species released by the European Committee on Antimicrobial Susceptibility Testing (as of July 2020) [15]"
| Species | Epidemiological cutoff (ECOFF) value (mg/L) | Cases |
|---|---|---|
| E. coli | 2.0 | 6014 |
| Klebsiella aerogenes | 2.0 | 266 |
| Klebsiella oxytoca | 2.0 | 405 |
| K. pneumoniae | 2.0 | 1805 |
| E. cloacae | 2.0 | 849 |
| P. aeruginosa | 4.0 | 19 482 |
| A. baumannii | 2.0 | 2879 |
Table 3
Table 4
The PK/PD (fAUC24 h /MIC) targets of polymyxins against various gram-negative bacteria"
| Drug | Animal model | Species | PK/PD target values required to achieve CFU reduction (medians) | |
|---|---|---|---|---|
| 1-log10 | 2-log10 | |||
| Colistin[ | Murine thigh infection | P. aeruginosa | 6.6 - 10.9 | 7.4 - 13.7 |
| Colistin[ | Murine thigh infection | A. baumannii | 3.5 - 13.9 | 7.4 - 17.6 |
| Colistin[ | Murine pneumonia | P. aeruginosa | 43.3 - 57.9 | 51.8 - 105 |
| Colistin[ | Murine pneumonia | A. baumannii | 20.8 | 36.8 |
| Polymyxin B[ | Murine hind limbs infection | K. pneumoniae | 3.7 - 28.0 | / |
Table 4
Table 5
The PTA and CFR derived from recommended CMS dosing regimens in terms of varying renal function levels"
| Dosing regimen | Sources | K. pneumoniae | E. coli | ||||
|---|---|---|---|---|---|---|---|
| PTA (%) | CFR | PTA (%) | CFR | ||||
| MIC50=0.5 | MIC90=2 | MIC50=0.5 & MIC90=0.5 | |||||
| CrCl ≥80 mL/min | |||||||
| 150 mg, q12h | EMA,[ | 92.7 | 64.4 | 85.4 | 92.7 | 90.4 | |
| 180 mg, q12h | Nation [ | 97.9 | 69.2 | 87.9 | 97.9 | 92.3 | |
| 150 mg, q8h | Siriraj Hospital regimen [ | 98.7 | 79.7 | 92.0 | 98.7 | 95.1 | |
| CrCl 51 to 79 mL/min | |||||||
| 114 mg, q12h | FDA [ | 96.0 | 72.0 | 89.9 | 96.0 | 94.1 | |
| 150 mg, q12h | Siriraj Hospital regimen,[ | 97.3 | 78.3 | 92.7 | 97.3 | 95.8 | |
| CrCl 30 to 50 mL/min | |||||||
| 150 mg, q12h | FDA [ | 97.6 | 71.1 | 91.3 | 97.6 | 95.6 | |
| 100 mg, q12h | Siriraj Hospital regimen [ | 98.9 | 85.7 | 95.7 | 98.9 | 97.9 | |
| 110 mg, q12h | Nation [ | 99.0 | 87.4 | 96.4 | 99.0 | 98.2 | |
| 125 mg, q12h | EMA [ | 99.2 | 89.8 | 97.2 | 99.2 | 98.5 | |
| CrCl 11 to 29 mL/min | |||||||
| 60 mg, q24h | FDA [ | 96.3 | 56.2 | 86.3 | 96.3 | 97.9 | |
| 150 mg, q24h | EMA,[ | 99.7 | 89.4 | 97.4 | 99.7 | 99.6 | |
| 180 mg, q24h | Nation [ | 99.6 | 89.3 | 97.4 | 99.6 | 99.9 | |
| CrCl ≤10 mL/min | |||||||
| 60 mg, q24h | FDA [ | 99.5 | 77.1 | 94.5 | 99.5 | 100 | |
| 120 mg, q24h | EMA [ | 99.9 | 94.9 | 98.9 | 99.9 | 100 | |
| 150 mg, q24h | Nation [ | 100 | 97.4 | 99.5 | 100 | 100 | |
Table 5
Table 6
The PTA derived from different polymyxin B dosing regimens in cystic fibrosis patients in terms of varying renal function levels [24]"
| CrCl (mL/min) | MIC (mg/L) | PTA of different polymyxin B dosing regimens (%) | ||||
|---|---|---|---|---|---|---|
| 1.5 mg/(kg·d) | 2.0 mg/(kg·d) | 2.5 mg/(kg·d) | 3.0 mg/(kg·d) | Loading dose 2.5 mg/kg + 2.5 mg/(kg·d) | ||
| 34 | 0.03125 | 100 | 100 | 100 | 100 | 100 |
| 0.0625 | 100 | 100 | 100 | 100 | 100 | |
| 0.125 | 100 | 100 | 100 | 100 | 100 | |
| 0.25 | 99.3 | 99.8 | 99.9 | 99.9 | 100 | |
| 0.5 | 19.0 | 64.0 | 97.0 | 99.3 | 99.8 | |
| 1 | 0.1 | 1.8 | 3.0 | 7.6 | 19.5 | |
| 2 | 0 | 0 | 0 | 0.1 | 1.7 | |
| 105 | 0.03125 | 100 | 100 | 100 | 100 | 100 |
| 0.0625 | 100 | 100 | 100 | 100 | 100 | |
| 0.125 | 96.0 | 99.0 | 100 | 100 | 100 | |
| 0.25 | 69.0 | 84.0 | 92.0 | 96.0 | 99.0 | |
| 0.5 | 15.0 | 38.0 | 57.9 | 70.0 | 81.0 | |
| 1 | 0.1 | 0.2 | 7.0 | 15.0 | 35.0 | |
| 2 | 0 | 0 | 0 | 0.1 | 1.7 | |
| 178 | 0.03125 | 100 | 100 | 100 | 100 | 100 |
| 0.0625 | 100 | 100 | 100 | 100 | 100 | |
| 0.125 | 74.0 | 97.0 | 99.0 | 100 | 100 | |
| 0.25 | 15.0 | 32.0 | 56.0 | 78.0 | 94.0 | |
| 0.5 | 1.0 | 4.0 | 8.0 | 15.0 | 27.0 | |
| 1 | 0 | 0 | 0.6 | 1 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | |
Table 6
Table 7
The PTA derived from recommended polymyxin B dosing regimens at indicated MIC levels * [26]"
| Dosing regimen | Body weight (kg) | PTA at indicated MIC level (%) | ||||||
|---|---|---|---|---|---|---|---|---|
| 0.125 mg/L | 0.25 mg/L | 0.5 mg/L | 1 mg/L | 2 mg/L | 4 mg/L | 8 mg/L | ||
| 100 mg q12h | ||||||||
| 50 | 100 | 100 | 100 | 39.1 | 2.0 | 0.2 | 0 | |
| 75 | 100 | 100 | 99.9 | 24.7 | 1.1 | 0.1 | 0 | |
| 110 | 100 | 100 | 94.3 | 16.5 | 0.8 | 0 | 0 | |
| 1 mg/kg TBW q12h | ||||||||
| 50 | 100 | 100 | 39.1 | 2 | 0.2 | 0 | 0 | |
| 75 | 100 | 100 | 82.1 | 7.7 | 0.3 | 0 | 0 | |
| 110 | 100 | 100 | 97.6 | 24.4 | 0.2 | 0.1 | 0 | |
| 1.5 mg/kg TBW q12h | ||||||||
| 50 | 100 | 100 | 93.5 | 10.7 | 0.3 | 0 | 0 | |
| 75 | 100 | 100 | 99.7 | 40.2 | 2.1 | 0.1 | 0 | |
| 110 | 100 | 100 | 100 | 74.7 | 7.6 | 0.3 | 0 | |
| Loading dose 2.5 mg/kg + 100 mg q12h | ||||||||
| 50 | 100 | 100 | 100 | 61.3 | 3.1 | 0.2 | 0 | |
| 75 | 100 | 100 | 100 | 81.3 | 8.2 | 0.3 | 0 | |
| 110 | 100 | 100 | 100 | 93.1 | 16.8 | 0.9 | 0 | |
| Loading dose 2.5 mg/kg + 1.5 mg/kg TBW q12h | ||||||||
| 50 | 100 | 100 | 100 | 45.0 | 2.0 | 0.2 | 0 | |
| 75 | 100 | 100 | 100 | 85.5 | 9.0 | 0.3 | 0 | |
| 110 | 100 | 100 | 100 | 98.2 | 26.8 | 1.5 | 0.1 | |
Table 7
Table 8
Polymyxin susceptibility testing report"
| Microorganism | Antimicrobial agent | MIC breakpoint (mg/L)c | Comment | |
|---|---|---|---|---|
| S | R | |||
| Enterobacterales a | Colistin or polymyxin Bb | ≤2 | ≥4 | Comments must be attached to the results of polymyxin susceptibility testing |
| P. aeruginosa | ≤2 | ≥4 | ||
| A. baumannii | ≤2 | ≥4 | ||
Table 8
Contributors
(in alphabetical order of family name)"
| Baiyi Chen | Department of Infectious Diseases, the First Affiliated Hospital of China Medical University |
|---|---|
| Yihai Gu | Department of Laboratory Medicine, Hanzhong 3201 Hospital |
| Li Gu | Department of Infectious Diseases, Beijing Chaoyang Hospital affiliated to Capital Medical University |
| Fupin Hu | Institute of Antibiotics, Huashan Hospital, Fudan University |
| Jihong Hu | National Center for Clinical Laboratories |
| Yunjian Hu | Department of Laboratory Medicine, Beijing Hospital |
| Zhidong Hu | Department of Laboratory Medicine, Tianjin Medical University General Hospital |
| Mei Kang | Department of Laboratory Medicine, West China Hospital, Sichuan University |
| Jian Li | Monash University, Australia |
| Junming Li | Department of Laboratory Medicine, the First Affiliated Hospital of Nanchang University |
| Xin Li | Department of Pharmacy, the Third Hospital of Changsha |
| Yi Li | Department of Laboratory Medicine, Henan Provincial People’s Hospital |
| Kang Liao | Department of Laboratory Medicine, the First Affiliated Hospital, Sun Yat-Sen University |
| Yongping Lin | Department of Laboratory Medicine, the First Affiliated Hospital of Guangzhou Medical University |
| Wen’en Liu | Department of Laboratory Medicine, Xiangya Hospital, Central South University |
| Yong Liu | Department of Laboratory Medicine, Shengjing Hospital affiliated to China Medical University |
| Youning Liu | Department of Respiratory Medicine, the First Medical Center of PLA General Hospital |
| Yuqing Liu | Shandong Academy of Agricultural Sciences |
| Zhengyin Liu | Department of Infectious Diseases, Peking Union Medical College Hospital |
| Zhiming Lu | Department of Laboratory Medicine, Shandong Provincial Hospital |
| Xiaoju Lv | Department of Infectious Diseases, West China Hospital, Sichuan University |
| Yuan Lv | Institute of Clinical Pharmacology, Peking University First Hospital |
| Xiaojun Ma | Department of Infectious Diseases, Peking Union Medical College Hospital |
| Xiaoling Ma | Department of Laboratory Medicine, the First Affiliated Hospital, University of Science and Technology of China |
| Dan Mei | Department of Pharmacy, Peking Union Medical College Hospital |
| Yuxing Ni | Department of Clinical Microbiology, Ruijin Hospital affiliated to Shanghai Jiao Tong University |
| Ziyong Sun | Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Tongwen Sun | General ICU, the First Affiliated Hospital of Zhengzhou University |
| Yiwei Tang | Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, USA |
| Minggui Wang | Institute of Antibiotics, Huashan Hospital, Fudan University |
| Rui Wang | Laboratory of Clinical Pharmacology, the First Medical Center of PLA General Hospital |
| Lianhua Wei | Department of Laboratory Medicine, Gansu Provincial People’s Hospital |
| Wenjuan Wu | Department of Laboratory Medicine, Shanghai East Hospital affiliated to Tongji University |
| Yingchun Xu | Department of Laboratory Medicine, Peking Union Medical College Hospital |
| Boren Xue | Department of Infectious Diseases, Affiliated Hospital of Taiwan University School of Medicine |
| Bin Yang | Department of Laboratory Medicine, the First Affiliated Hospital of Fujian Medical University |
| Qiwen Yang | Department of Laboratory Medicine, Peking Union Medical College Hospital |
| Qing Yang | Department of Laboratory Medicine, the First Affiliated Hospital of Zhejiang University School of Medicine |
| Yunsong Yu | Department of Infectious Diseases, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine |
| Hua Yu | Department of Laboratory Medicine, Sichuan Provincial People’s Hospital |
| Jing Zhang | Institute of Antibiotics, Huashan Hospital, Fudan University |
| Xiuzhen Zhang | Department of Laboratory Medicine, Beijing Hospital |
| Jianhong Zhao | Department of Laboratory Medicine, the Second Hospital of Hebei Medical University |
| Bo Zheng | Department of Infection, Peking University People’s Hospital |
| Demei Zhu | Institute of Antibiotics, Huashan Hospital, Fudan University |
| Lei Zhu | Department of Laboratory Medicine, Shanxi Children’s Hospital |
| Chao Zhuo | Guangzhou Institute of Respiratory Health |
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