Table 3.
Definitions Of Clinical Outcome (response) Parameters
| HAP/VAP/HCAP | BSI/Sepsis | cUTI | |
|---|---|---|---|
| EA, EOT, TOC | |||
| Clinical cure | Resolution or substantial improvement of baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy is required for the treatment of the current infection. | Resolution or substantial improvement of baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy is required for the treatment of BSI/sepsis. Patients with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. | Resolution or substantial improvement of baseline signs and symptoms of cUTI, or return to pre-infection baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. |
| Clinical failure | No apparent response to therapy; persistence or worsening of baseline signs and/or symptoms of pneumonia; reappearance of signs and/or symptoms of pneumonia; development of new signs and/or symptoms of pneumonia requiring antibiotic therapy other than, or in addition to, study treatment therapy; progression of chest radiographic abnormalities; or death due to pneumonia. | No apparent response to therapy; persistence or worsening of baseline signs and/or symptoms, reappearance of signs and/or symptoms; development of new signs and/or symptoms requiring antibiotic therapy other than, or in addition to, study treatment therapy; or death due to BSI/sepsis. | No apparent response to therapy; persistence or worsening of baseline signs and/or symptoms of cUTI; or reappearance of signs and/or symptoms of cUTI; development of new signs and/or symptoms of cUTI requiring antibiotic therapy other than, or in addition to, study treatment therapy; or death due to cUTI. |
| Indeterminate | Lost to follow-up such that a determination of clinical cure/failure cannot be made. | Lost to follow-up such that a determination of clinical cure/failure cannot be made. | Lost to follow-up such that a determination of clinical cure/failure cannot be made. |
| FUP | |||
| Sustained clinical cure | Continued resolution or substantial improvement of baseline signs and symptoms of pneumonia, such that no antibacterial therapy is required for the treatment of pneumonia in a patient assessed as cured at TOC. | Continued resolution or substantial improvement of baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy is required for the treatment of the original BSI/sepsis in a patient assessed as cured at TOC. | Continued resolution or improvement of baseline signs and symptoms of cUTI, or return to pre-infection baseline if known, in a patient assessed as cured at TOC. |
| Relapse | Recurrence of signs and/or symptoms of pneumonia, appearance of new signs and/or symptoms of pneumonia, new chest radiographic evidence of pneumonia, or death due to pneumonia in a patient assessed as cured at TOC. | Recurrence of signs and/or symptoms of BSI/sepsis, appearance of new signs and/or symptoms of the original BSI/sepsis, or death due to BSI/sepsis in a patient assessed as cured at TOC. | Recurrence of signs and/or symptoms of cUTI, or appearance of new signs and/or symptoms of cUTI in a patient assessed as cured at TOC. |
| Indeterminate | Lost to follow-up such that a determination of clinical sustained cure/relapse cannot be made, or patient received additional antibacterial therapy for the treatment of the current infection. | Lost to follow-up such that a determination of clinical sustained cure/relapse cannot be made, or patient received additional antibacterial therapy for the treatment of the current infection. | Lost to follow-up such that a determination of clinical sustained cure/relapse cannot be made, or patient received additional antibacterial therapy for the treatment of the current infection. |
Abbreviations: HAP, hospital-acquired pneumonia; VAP, ventilator-associated pneumonia; HCAP, healthcare-associated pneumonia; BSI, bloodstream infection; cUTI, complicated urinary tract infection; EA, early assessment; EOT, end of therapy; TOC, test of cure; SOFA, Sequential Organ Failure Assessment; CPIS, Clinical Pulmonary Infection Score.