delafloxacin
Regulatory sources consulted
Approved indications
- Acute bacterial skin and skin-structure infections and community-acquired bacterial pneumonia caused by susceptible organisms.
Contraindications
Absolute
- Hypersensitivity to delafloxacin or other fluoroquinolones; pregnancy; woman of childbearing potential without contraception; breastfeeding; age under 18 years.
Clinical warnings
- It may cause tendinitis or tendon rupture, peripheral neuropathy, and disabling or potentially irreversible central nervous system effects; discontinue immediately at the first symptoms. — DailyMed, set_id fb77637a-88d9-4aea-958f-e270030ce30d
- It may exacerbate myasthenia gravis and cause respiratory weakness; avoid in patients with a known history. — DailyMed, set_id fb77637a-88d9-4aea-958f-e270030ce30d
- Major warning · It has been associated with aortic aneurysm or dissection; avoid in high-risk patients unless no alternatives exist and seek emergency care for sudden chest, abdominal, or back pain. — DailyMed, set_id fb77637a-88d9-4aea-958f-e270030ce30d
- Major warning · It may disturb blood glucose, including severe hypoglycemia; monitor glucose in people with diabetes and discontinue with a significant disturbance. — DailyMed, set_id fb77637a-88d9-4aea-958f-e270030ce30d
- Major warning · Clostridioides difficile-associated diarrhea and colitis may occur during or after treatment; assess significant diarrhea and discontinue if confirmed. — DailyMed, set_id fb77637a-88d9-4aea-958f-e270030ce30d
Drug interactions
- HighAntacids and supplements containing multivalent cations
Mechanism: Aluminum, magnesium, calcium, iron, and zinc form chelates and markedly reduce oral absorption.
Recommendation: Separate doses according to the product-specific interval.
DailyMed, set_id fb77637a-88d9-4aea-958f-e270030ce30d
Adverse events
Common (≥1%)
Nausea, diarrhea, headache, and dizziness
Rare but serious
Tendon rupture, persistent peripheral neuropathy, severe neuropsychiatric reaction, anaphylaxis, and aortic dissection
Pregnancy and lactation
It is contraindicated during pregnancy and in women of childbearing potential without contraception. During breastfeeding, decide whether to discontinue breastfeeding or treatment according to maternal benefit.
Recent literature (PubMed)
Pneumonia, classified as a lower respiratory tract illness, affects different parts of the bronchial system as well as alveoli and can present with varying severities depending on co-morbidities and causative pathogens. It can be broadly classified using the setting in which it was acquired, namely the community or hospital setting, the former being more common and spreading through person-to-person droplet transmission. Community-acquired pneumonia (CAP) is currently the fourth leading cause of death worldwide, and its high mortality makes continual insight into the management of the condition worthwhile. This review explores the literature specifically for severe CAP (sCAP) and delves into the diagnosis, various modalities of treatment, and management of the condition. This condition can be defined as pneumonia requiring mechanical ventilation in the ICU and/or presenting with sepsis and organ failure due to pneumonia. The disease process is characterized by inflammation of the lung parenchyma, initiated by a combination of pathogens and lowered local defenses. Acute diagnosis of the condition is vital in reducing negative patient outcomes, namely through clinical presentation, blood/sputum cultures, imaging modalities such as computed tomography scan, and inflammatory markers, identifying common causative pathogens such as Streptococcus pneumoniae, rhinovirus, Legionella, and viral influenza. Pathogens such as Escherichia coli should also be investigated in patients with chronic obstructive pulmonary disease. The mainstay of treating sCAP includes rapid ICU admission once a diagnosis has been confirmed, initiating sepsis protocol, and treatment with combined empiric antibiotic regimens consisting of beta-lactams and macrolides. Corticosteroid use alongside antibiotics shows promise in reducing inflammation, but its use has to be judged on a case-by-case basis. New drugs such as omadacycline, delafloxacin, and zabofloxacin have shown valid evidence for the treatme
Antimicrobial resistance stands as one of the most urgent global health concerns in the twenty-first century, with projections suggesting that deaths related to drug-resistant infections could escalate to 10 million by 2050 if proactive measures are not implemented. In intensive care settings, managing infections caused by multidrug-resistant (MDR) Gram-negative bacteria is particularly challenging, posing a significant threat to public health and contributing substantially to both morbidity and mortality. There are numerous studies on the antibiotics responsible for resistance in Gram-negative bacteria, but comprehensive research on resistance mechanisms against new antibiotics is rare. Considering the possibility that antibiotics may no longer be effective in combating diseases, it is crucial to comprehend the problem of emerging resistance to newly developed antibiotics and to implement preventive measures to curb the spread of resistance. Mutations in porins and efflux pumps play a crucial role in antibiotic resistance by altering drug permeability and active efflux. Porin modifications reduce the influx of antibiotics, whereas overexpression of efflux pumps, particularly those in the resistance-nodulation-cell division (RND) family, actively expels antibiotics from bacterial cells, significantly lowering intracellular drug concentrations and leading to treatment failure.This review examines the mechanisms of action, resistance profiles, and pharmacokinetic/pharmacodynamic characteristics of newly developed antibiotics designed to combat infections caused by MDR and carbapenem-resistant Gram-negative pathogens. The antibiotics discussed include ceftazidime-avibactam, imipenem-relebactam, ceftolozane-tazobactam, meropenem-vaborbactam, aztreonam-avibactam, delafloxacin, temocillin, plazomicin, cefiderocol, and eravacycline.
Delafloxacin (BAXDELA® in the USA; Quofenix® in the EU) is an anionic fluoroquinolone antibacterial that is approved for the treatment of community-acquired pneumonia (CAP) and acute bacterial skin and skin structure infections in adults. Delafloxacin demonstrated in vitro activity against Gram-positive and Gram-negative pathogens, including drug-resistant isolates. In a phase III trial in adults with CAP, delafloxacin was noninferior to moxifloxacin when assessed against FDA- and EMA-defined primary endpoints, with both fluoroquinolones achieving high treatment success rates. A prespecified subgroup analysis suggested that delafloxacin may be more efficacious than moxifloxacin in patients with a history of asthma or chronic obstructive pulmonary disease (COPD). Delafloxacin was generally well tolerated in patients with CAP, with most treatment-emergent adverse events graded as mild or moderate in severity. Fluoroquinolone-associated adverse events of special interest occurred infrequently, with no events of QT prolongation or phototoxicity reported with delafloxacin. Delafloxacin is an effective and generally well-tolerated treatment that increases the number of available treatments for CAP and, although further research is required, may be a useful option for patients with CAP and comorbid asthma or COPD. Community-acquired pneumonia (CAP) can be caused by bacterial infection of the lungs, and is a common cause of infection-related deaths. As drug-resistant bacteria are becoming more common, new antibacterial drugs are needed. Delafloxacin (BAXDELA® in the USA; Quofenix® in the EU) is a fluoroquinolone antibacterial that inhibits bacterial enzymes required for DNA repair and replication. Delafloxacin kills a wide range of bacteria, including some drug-resistant variants. During a trial in adults with CAP, delafloxacin was as effective as moxifloxacin (also a fluoroquinolone antibacterial). Delafloxacin may be more effective than moxifloxacin in patients with a his
This review discusses small molecule antibiotics approved for clinical use in the time frame 2010-2022. This time span saw the approval of four synthetic antibiotics (bedaquiline, pretomanid, delafloxacin, tedizolid), nine natural product derivatives (ceftaroline fosamil, cefiderocol, plazomicin, omadacycline, eravacycline, sarecycline, lefamulin, dalbavancin, oritavancin), and one natural product (fidaxomicin).