Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZTI-01 · 1 trial · 3 indications
Clinical cure (resolution or significant improvement in signs and symptoms) and microbiologic eradication (baseline pathogen) in m-MITT population
| Arm | Type | Description |
|---|---|---|
| ZTI-01 | EXPERIMENTAL | 6 g ZTI-01 (IV fosfomycin) intravenously administered every 8 hours (18g total daily dose for 7-14 calendar days) |
| piperacillin tazobactam | ACTIVE_COMPARATOR | 4.5 g piperacillin/tazobactam (4 g piperacillin/0.5 g tazobactam) intravenously administered every 8 hours (13.5g total daily dose for 7-14 calendar days) |
| Name | Type | Description |
|---|---|---|
| ZTI-01 | DRUG | 6g ZTI-01 intravenous infusion TID q8 hours |
| Piperacillin-tazobactam | DRUG | 4.5g piperacillin-tazobactam intravenous infusion TID q8 hours |
Inclusion Criteria: 1. A signed informed consent form (ICF); 2. Male or female, at least 18 years of age; 3. Diagnosis requires hospitalization and treatment with intravenous (IV) antibiotics; 4. Documented or suspected cUTI or AP including at least 2 protocol defined signs and symptoms and a urine...