TABLE 1.
Patient no. | K. pneumoniae strain no. | Polymyxin B MIC (mg/L) | Treatment duration (day) | Study completion per protocol (Withdrawal reasons) | Continued polymyxin B treatment after withdrawal | AUC24 h,ss/MIC | Microbiological efficacy | Clinical efficacy** | 28-day survival |
---|---|---|---|---|---|---|---|---|---|
1 | 1 | .5 | 6 | Withdraw (AKI) | Yes | 110.4 | Eradication | Not improved | - |
2 | 2–1, 2–2* | .5, .5 | 6 | Withdraw (AKI) | Yes | 266.8 | Eradication | Improved | - |
3 | 3 | 1 | 14 | Yes | - | 68.8 | Eradication | Cure | Yes |
Withdraw (pruritus and numbness on face and head, ataxia) | |||||||||
4# | 4 | .5 | 1 | No | - | - | - | - | |
Withdraw (AKI, pruritus and numbness on face and head, ataxia) | |||||||||
5 | 5 | .5 | 5 | No | 172 | Eradication | Improved | - | |
6 | 6 | .5 | 14 | Yes | - | 149.6 | Eradication | Cure | Yes |
7 | 7 | 1 | 14 | Yes | - | 87.8 | Eradication | Cure | Yes |
Withdraw (AKI, pruritus and numbness on face and head, ataxia) | |||||||||
8 | 8 | .5 | 4 | Yes | 154.4 | Eradication | Improved | - | |
9 | 9 | 1 | 14 | Yes | - | 54.4 | Eradication | Failure | Yes |
MIC, minimum inhibitory concentration; AUC24 h,ss, area under the plasma concentration-time curve across 24 h at steady state; *, two CRKP strains were isolated; -, not applicable or not evaluated; **, evaluated when the subjects withdrew or completed the study; #, the PK/PD and efficacy could not be evaluated as the patient withdrew after receiving only the loading dose. All strains had a meropenem MIC of >64 mg/L except for strain No. 2–2 (MIC of 4 mg/L).