TABLE 4.
Primary endpoint (overall response) definition by infection typec
| Infection type | Time point | Outcome |
|---|---|---|
| HABP/VABP | Day 28 | All-cause mortality (survival) |
| cIAI | Day 28 | Favorable clinical response (sustained cure or curea ) |
| cUTI | EFU visit | Favorable microbiological response (sustained eradicationb ) and favorable clinical response (sustained cure or curea ) |
All pretherapy signs and symptoms of the index infection(s) had resolved (or returned to preinfection status), no additional intravenous antibiotic therapy was required, and, for patients with cIAI, no unplanned surgical procedures or percutaneous drainage procedures had been performed (cure was sustained if there was no evidence of a resurgence of the index infection).
A culture of urine taken at the EFU visit still showed eradication of the uropathogen found at study entry (i.e., a count of ≥105 CFU/ml was reduced to <104 CFU/ml).
cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; EFU, early follow-up; HABP, hospital-acquired bacterial pneumonia; VABP, ventilator-associated bacterial pneumonia.