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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01496352 | DFA-02 in Patients Undergoing Colorectal Surgery | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 2012 | Jun 1, 2013 | Sep 1, 2014 | 5 | United States |
Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
| Arm | Type | Description |
|---|---|---|
| DFA-02 | EXPERIMENTAL | Progressive cohorts of 10 subjects (8 active, 2 placebo) receiving 10, 20 , 30 or 40 mL of DFA-02 or matching placebo. |
| DFA-02 placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DFA-02 | DRUG | Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure |
| Placebo | DRUG | DFA-02 placebo |
Inclusion Criteria: 1. Males and females 18 years of age or older; 2. If female, the patient must be: * postmenopausal (if amenorrheic for \< 1 year, postmenopausal status must be confirmed by an elevated follicle stimulating hormone \[FSH\] level \> 30 mIU/mL; if amenorrheic for \> 1 year, FSH...