Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00921024 | Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections | PHASE2 | COMPLETED | 129 | — | — | Jun 30, 2009 | Mar 11, 2010 | Oct 18, 2018 | 21 | United States, Germany +1 |
Microbiological response is eradication for each baseline pathogen
Microbiological response is eradication for each baseline pathogen
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | CXA-101 |
| 2 | ACTIVE_COMPARATOR | Ceftazidime |
| Name | Type | Description |
|---|---|---|
| CXA-101 | DRUG | intravenous |
| Ceftazidime | DRUG | intravenous |
Inclusion Criteria: 1. Males and females 18 to 90 years of age, inclusive. 2. Pyuria (white blood cell \[WBC\] count \> 10/µL in unspun urine or ≥ 10 per high power field in spun urine) 3. Clinical signs and/or symptoms of cUTI, either of: a. Pyelonephritis, as indicated by both of the followin...