Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Delafloxacin · 8 trials · 9 indications
Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.
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.
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
| Arm | Type | Description |
|---|---|---|
| Delafloxacin | EXPERIMENTAL | IV delafloxacin with potential to switch to oral delafloxacin |
| Moxifloxacin/Linezolid | ACTIVE_COMPARATOR | IV moxifloxacin with potential to switch to oral moxifloxacin, and potential to switch moxifloxacin to IV linezolid for confirmed MRSA |
| 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 |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | ACTIVE_COMPARATOR | - |
| Midazolam/Delafloxacin | EXPERIMENTAL | Each subject will receive a single 5 mg oral dose of midazolam syrup on Day 1, oral 450 mg delafloxacin tablets twice daily (Q12h) for Days 3 to 8, and co-administered a single 5 mg oral dose of midazolam syrup in the AM on Day 8. |
| Name | Type | Description |
|---|---|---|
| Delafloxacin | DRUG | Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total |
| Moxifloxacin | DRUG | Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total |
| Linezolid | DRUG | Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses |
| vancomycin | DRUG | - |
| aztreonam | DRUG | - |
| Placebo | DRUG | Placebo |
| tigecycline | DRUG | 100 mg then 50 mg intravenous tigecycline every 12 hours |
| Midazolam | DRUG | Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8. |
Inclusion Criteria: 1. Male or female 18 years of age or older 2. Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening) * Cough * Production of purulent sputum consistent with bacterial infection * Difficulty breathing * Chest pain due to pneumonia...
Delafloxacin is an investigational small molecule being studied for infectious disease indications including community acquired bacterial pneumonia, skin structure infections, and skin and subcutaneous tissue bacterial infections. It is also being evaluated in the context of hepatic impairment and drug interactions. The drug is in Phase 3 clinical development.
Delafloxacin is a fluoroquinolone antibiotic that works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication. This mechanism is typical of the fluoroquinolone class. The drug is being developed for the treatment of bacterial infections.
Delafloxacin is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker CRMD. The company is conducting clinical trials to evaluate the drug for the treatment of acute bacterial skin and skin structure infections and other infectious disease indications.
Delafloxacin is in Phase 3 clinical development. It has completed three trials, including two Phase 3 studies and one Phase 2 study, with a total enrollment of 1,766 participants. The drug is investigational and has not been approved by regulatory authorities.
Delafloxacin has completed three clinical trials. NCT01811732 and NCT01984684 are Phase 3 studies comparing Delafloxacin to vancomycin plus aztreonam for acute bacterial skin and skin structure infections. NCT01283581 is a Phase 2 study assessing objective endpoint measurements of response in bacterial skin infections.
Delafloxacin is the generic name for the drug also known by the brand name Baxdela. It is a fluoroquinolone antibiotic being developed for the treatment of acute bacterial skin and skin structure infections and community acquired bacterial pneumonia.