Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CF-301 · 2 trials · 3 indications
Number and percentage of patients with treatment-emergent adverse events (TEAEs)
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) population. Responder (clinical outcome of improvement or response) was defined as survival with improvement or resolution of attributable signs and symptoms, and without new signs or symptoms, new foci of infection, change in antibiotics due to non-response, complications of S. aureus, or further surgery or medical intervention to treat S. aureus.
CF-301 plasma concentrations at specified timepoints.
CF-301 plasma concentrations at specified time points
Safety and tolerability will be assessed by monitoring AEs and performing physical/clinical examinations.
| Arm | Type | Description |
|---|---|---|
| CF-301 | EXPERIMENTAL | Patients will receive a single IV infusion of CF-301 in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
| Placebo | PLACEBO_COMPARATOR | Patients will receive a single IV infusion of placebo in addition to standard of care (SOC) antibacterial therapy selected by the investigator. |
| Name | Type | Description |
|---|---|---|
| CF-301 | BIOLOGICAL | CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion |
| Placebo | DRUG | Placebo, given as a single 2 hour iv infusion |
Inclusion Criteria: * male or female, 18 years or older * blood culture positive for S. aureus * at least one sign or symptom attributable to S. aureus bacteremia * known or suspected complicated S. aureus BSI and/or endocarditis by Modified Duke Criteria * patient is not pregnant or breastfeeding ...