Advice
Advisory statement on likely place in therapy
Delafloxacin may be an option for community-acquired pneumonia in adults for exceptional cases when other antibacterial agents that are usually recommended for this are not suitable. Take account of local antimicrobial resistance and seek specialist microbiological advice. See the recommendations in the NICE guideline on antimicrobial prescribing for community-acquired pneumonia for first-choice antibiotics, antibiotics for people with suspected atypical pathogens and alternative options for people with penicillin allergy. Follow recommendations on new antimicrobials in the NICE guideline on antimicrobial stewardship: systems and processes.
Rationale
A wide range of antimicrobials, alone or in combination, are used for treating community-acquired pneumonia, depending on the severity of symptoms, risk of atypical pathogens, penicillin allergy and any microbiological results. The European public assessment report variation for delafloxacin states that delafloxacin 'does not address an unmet need in the treatment of community-acquired pneumonia, but it does provide an additional antimicrobial option.'
Evidence from 1 randomised controlled trial in 859 adults with community-acquired bacterial pneumonia treated in a non-UK setting found that delafloxacin was non-inferior to moxifloxacin for early clinical response after 96 hours of treatment. Evidence also found that delafloxacin was non-inferior to moxifloxacin for clinical response at test of cure.
Approximately 91% of the study population had a CURB-65 score of 2 or less, indicating low to moderate severity pneumonia (see Lim et al. 2003 for an explanation of the CURB-65 scale). The NICE antimicrobial prescribing guideline recommends a fluoroquinolone antibiotic (levofloxacin) as a treatment option only for high severity community-acquired pneumonia (CURB-65 score 3 to 5) in adults who have penicillin allergy.
All participants in the study had intravenous antimicrobial treatment. This could be switched to oral treatment if clinical criteria were met. There is currently no published evidence using oral delafloxacin alone for community-acquired pneumonia. However, the intravenous infusion and tablet formulations are bioequivalent (see the summary of product characteristics for delafloxacin). There are no published clinical studies that compare delafloxacin to any other fluoroquinolones or to other classes of antimicrobials.
There are safety concerns associated with fluoroquinolone treatment. The Medicines and Healthcare products Regulatory Agency (MHRA) has recommended prescribing restrictions and precautions for fluoroquinolone antibiotics due to very rare reports of disabling and potentially long-lasting or irreversible side effects (see the Drug Safety Update March 2019). The MHRA has also advised healthcare professionals about small increased risks of aortic aneurysm and dissection, and heart valve regurgitation associated with the fluoroquinolones (see the Drug Safety Update November 2018 and the Drug Safety Update December 2020).
The NICE guideline on antimicrobial stewardship: systems and processes makes recommendations on the effective use of new antimicrobials. Delafloxacin should be reserved for those people most likely to benefit from it, after specialist microbiological advice to help monitor use and limit antimicrobial resistance.