Table 3.
Clinical and Microbiological Outcomes by Baseline Pathogen at Test of Cure (Microbiologic Modified Intent-to-Treat, Post Hoc Pulsed-field Gel Electrophoresis Analysisa)
| Baseline Pathogen | Clinical Cure | Microbiologic Eradication | ||
|---|---|---|---|---|
| ZTI-01, n/N (%) | PIP-TAZ, n/N (%) | ZTI-01, n/N (%) | PIP-TAZ, n/N (%) | |
| Escherichia coli | 120/133 (90.2) | 120/133 (90.2) | 97/133 (72.9) | 84/133 (63.2) |
| Klebsiella pneumoniae | 25/27 (92.6) | 25/25 (100) | 18/27 (66.7) | 14/25 (56.0) |
| Proteus mirabilis | 8/9 (88.9) | 3/5 (60.0) | 8/9 (88.9) | 1/5 (20.0) |
| Enterobacter cloacae species complex | 8/9 (88.9) | 3/3 (100) | 6/9 (66.7) | 3/3 (100) |
| Klebsiella oxytoca | 2/3 (66.7) | 2/2 (100) | 2/3 (66.7) | 2/2 (100) |
| Raoultella ornithinolytica | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) |
| Serratia marcescens | 1/1 (100) | 1/1 (100) | 1/1 (100) | 0/1 (0) |
| Morganella morganii | 0/0 (…) | 1/1 (100) | 0/0 (…) | 1/1 (100) |
| Citrobacter amalonaticus/farmer | 1/1 (100) | 0/0 (…) | 1/1 (100) | 0/0 (…) |
| Pseudomonas aeruginosa | 8/8 (100) | 9/9 (100) | 3/8 (37.5) | 4/9 (44.4) |
| Acinetobacter baumannii-calcoaceticus species complex | 2/2 (100) | 0/0 (…) | 2/2 (100) | 0/0 (…) |
| Enterococcus faecalis | 2/3 (66.7) | 6/7 (85.7) | 1/3 (33.3) | 4/7 (57.1) |
| Staphylococcus aureus | 1/1 (100) | 0/0 (…) | 1/1 (100) | 0/0 (…) |
| Staphylococcus saprophyticus | 0/0 (…) | 1/1 (100) | 0/0 (…) | 1/1 (100) |
Percentages were calculated using N as the denominator, where N was the number of patients with the specified pathogens. If both a urine and blood sample had the same pathogen at baseline, eradication was defined as the baseline bacterial pathogen was reduced to <104 colony-forming unit/mL on urine culture and was negative on repeat blood culture.
Abbreviations: PIP-TAZ, piperacillin-tazobactam; ZTI-01, fosfomycin for injection.
aPulsed-field gel electrophoresis was performed to molecularly type all baseline and test-of-cure pathogens (both treatment arms), in order to confirm microbiological eradication/persistence; a total of 20 postbaseline pathogens were identified as unique, unrelated strains compared to baseline.