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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01984684 | Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections | PHASE3 | COMPLETED | 850 | — | — | May 1, 2014 | Jan 1, 2016 | Nov 17, 2017 | 94 | United States, Argentina +14 |
| NCT01811732 | Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections | PHASE3 | COMPLETED | 660 | — | — | Apr 1, 2013 | Jul 1, 2014 | Sep 27, 2017 | 50 | United States, Croatia +5 |
| NCT01283581 | A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections | PHASE2 | COMPLETED | 256 | — | — | Jan 1, 2011 | Nov 1, 2011 | Oct 16, 2019 | 31 | United States |
A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had \<20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.
A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had \<20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.
The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
| Arm | Type | Description |
|---|---|---|
| Delafloxacin | EXPERIMENTAL | Delafloxacin 300 mg IV Q12H for 6 doses, then Delafloxacin 450 mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total |
| Vancomycin plus Aztreonam | ACTIVE_COMPARATOR | Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 up to a maximum of 28 doses total (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures) |
| Delafloxacin plus placebo | EXPERIMENTAL | Delafloxacin 300 mg IV every 12 hours for a minimum of 10 and up to a maximum of 28 doses |
| Vancomycin plus Aztreonam + placebo | ACTIVE_COMPARATOR | Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses (Aztreonam was discontinued as soon as possible if a gram-negative organism was not identified in baseline cultures) |
| Vancomycin | ACTIVE_COMPARATOR | 15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas |
| Linezolid | ACTIVE_COMPARATOR | 600 mg IV every 12 hours for 5-14 days |
| Name | Type | Description |
|---|---|---|
| delafloxacin | DRUG | - |
| vancomycin | DRUG | - |
| aztreonam | DRUG | - |
| Placebo | DRUG | Placebo |
| Linezolid | DRUG | 600mg IV every 12 hours for 5-14 days |
Inclusion Criteria: * Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm\^2 and at least two signs of systemic infection * In the opinion o...