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Label indication BAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ( 1.1 ) Community-Acquired Bacterial Pneumonia (CABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be… FDA label
Also known as RX-3341
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 antibiotic being studied for treating bacterial infections, including community acquired bacterial pneumonia, skin structure infections, and skin and subcutaneous tissue bacterial infections. It is also being evaluated in patients with hepatic impairment and for drug interaction potential. It is a small molecule developed by CorMedix Inc. (CRMD).
Delafloxacin is being developed by CorMedix Inc., which trades under the ticker CRMD. CorMedix is the sponsor of the clinical program evaluating delafloxacin across infectious disease indications, including community acquired bacterial pneumonia and skin infections.
Delafloxacin is in Phase 3 clinical development. The Phase 3 program includes a completed study comparing delafloxacin to moxifloxacin in adults with community acquired bacterial pneumonia. Additional completed Phase 1 studies evaluated pharmacokinetics in healthy adults, hepatic impairment, and drug interaction potential. It remains an investigational agent.
Delafloxacin has been studied in completed trials including NCT02679573, a Phase 3 comparison with moxifloxacin in community acquired bacterial pneumonia; NCT03534622, a Phase 1 bronchopulmonary disposition study in healthy adults; NCT02505997, a Phase 1 drug interaction study with midazolam; and NCT02245243, a Phase 1 pharmacokinetic study in hepatic impairment.
Delafloxacin is an investigational drug and has not been approved by the FDA for the indications studied in this program. It remains in clinical development, with completed Phase 3 and Phase 1 trials evaluating its use in community acquired bacterial pneumonia, skin infections, hepatic impairment, and drug interactions.
Across the clinical program, 1,766 participants have been enrolled in delafloxacin trials. These include a Phase 3 study in community acquired bacterial pneumonia with 860 participants and several Phase 1 studies in healthy volunteers and patients with hepatic impairment. The trials were randomized, double blind, and active controlled.