Table 4.
Definitions and time points used in clinical studies to define mortality, clinical cure, microbiological cure, and infection relapse.
| Outcomes | Definitions or time points | References |
|---|---|---|
| Mortality | All-cause mortality by day-30 | (49, 50, 52–57, 60, 63, 65) |
| In-hospital all-cause mortality | (51, 56, 61, 62) | |
| All-cause mortality by day-90 | (15, 48, 58) | |
| All-cause mortality by day-28 | (64) | |
| All-cause mortality by day-14 | (56, 66) | |
| Clinical cure | Resolution of presenting symptoms and signs of the infection by the end of therapy | (49–51, 56, 61, 63) |
| Resolution of fever and other signs and symptoms attributable to infection in the absence of relapse by day-14 | (57) | |
| Resolution of fever and other signs and symptoms attributable to infection in the absence of relapse by day-30 | (58) | |
| Resolution of signs and symptoms, survival, absence of relapse and absence of microbiological failure by day-30 | (59) | |
| Resolution of signs and symptoms, survival and absence of relapse by day-30 and microbiological cure within 7 days | (15) | |
| Resolution of signs and symptoms within 7 days of treatment initiation | (65) | |
| Absence of death, infection relapse and signs and symptoms at day-14 | (60) | |
| Discharge from the hospital | (62) | |
| Resolution of signs and symptoms when antibiotics are discontinued, survival by day-30, sterilization of blood culture within 7 days for bacteremic cases, absence of relapse by day-90 | (48) | |
| Microbiological cure | Eradication of microorganism at the end of therapy | (49–51) |
| Negative blood culture 72 h after treatment onset | (56) | |
| Eradication of microorganism within 7 days of treatment | (56, 59) | |
| Eradication of the microorganism at the end of therapy and/or within 7 days of treatment | (65) | |
| Eradication of microorganism at 30-day | (53, 60) | |
| Infection relapse | Presence of same microorganism at the same location within 90-days of the index infection | (48, 57) |
| Presence of same microorganism at the same location during the follow-up | (49) | |
| Microbiological failure and concomitant signs of infection within 90 days | (65) | |
| Onset of a second microbiologically documented KPC-KP infection in a patient whose original infection had been classified as a clinical cure | (54, 56) | |
| Emergence of recurrent BSI during hospitalization | (62) | |
| Reinfection with the same organism within 30 days after completion of therapy | (63) |