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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02563106 | A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI | PHASE2 | COMPLETED | 413 | — | — | Oct 1, 2015 | Nov 1, 2016 | Nov 27, 2018 | 43 | United States, Bulgaria +5 |
Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B \[or their respective genes, tcdA and/or tcdB\], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.
| Arm | Type | Description |
|---|---|---|
| SYN-004 | EXPERIMENTAL | SYN-004 150 mg |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| SYN-004 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Expected minimum hospital stay of 5 days * Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide * Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract...