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Next Generation Macrolides for Community-Acquired Pneumonia: Will Solithromycin Rise to the Occasion?

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Next Generation Macrolides for Community-Acquired Pneumonia: Will Solithromycin Rise to the Occasion? Editorial Page 1 of 5 Next generation macrolides for community-acquired pneumonia: will solithromycin rise to the occasion? Ricardo J. José Centre for Inflammation and Tissue Repair, UCL Respiratory, 5 University Street, London WC1E6JF, UK Correspondence to: Ricardo J. José. Centre for Inflammation and Tissue Repair, UCL Respiratory, 5 University Street, London WC1E6JF, UK. Email: [email protected]. Provenance: This is a Guest Editorial commissioned by Section Editor Mi Zhou, MM, (No. 152 Central Hospital of PLA, Pingdingshan, China). Comment on: File TM Jr, Rewerska B, Vucinić-Mihailović V, et al. SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia. Clin Infect Dis 2016;63:1007-16. Received: 09 January 2017; Accepted: 10 January 2017; Published: 07 April 2017. doi: 10.21037/arh.2017.04.11 View this article at: http://dx.doi.org/10.21037/arh.2017.04.11 Community-acquired pneumonia (CAP) remains the administration. Whilst intravenous formulations are useful leading cause of death by an infectious disease (1). Although for those who are clinically unstable or unable to take the aetiological agent varies by geographical location and medication orally, by ensuring optimal bioavailability, this population studied, in adults the most commonly isolated is associated with increased cost and infusion site adverse pathogens from adult CAP patients are bacteria. Despite events. It is therefore important to ensure that when the poor detection rate of CAP organisms by current appropriate antibiotics are switched from intravenous to microbiological techniques (2), Streptococcus pneumoniae oral formulations, provided the same efficacy exists. continues to be the most frequently isolated pathogen (3) The antibiotic recommendations for the treatment and is responsible for the huge burden associated with of CAP differ by guidelines and are based on knowledge this disease. Other commonly isolated bacterial species of local causative pathogens, antibiotic resistance include Haemophilus influenzae, Mycoplasma pneumoniae, patterns and patient illness severity. The Infectious Chlamydophila pneumoniae and Legionella pneumophila. Less Disease Society of America/American Thoracic Society regularly Enterobacteriaceae, Pseudomonas aeruginosa, guideline (4) recommends that in the outpatient setting Klebsiella pneumoniae, Moraxella Catarrhalis, Chlamydia previously healthy individuals living in areas of low psittaci and Coxiella Burnetii are identified. With improved macrolide resistance should be treated with a macrolide molecular diagnostics, viruses are increasingly being (e.g., erythromycin, clarithromycin or azithromycin) or recognised as important pathogens in CAP particularly as doxycycline, whilst those with co-morbidities, those in they predispose the host to secondary bacterial infection. areas with high macrolide resistance or those admitted Treatment of CAP therefore requires the use of antibiotics to hospital should receive a respiratory fluoroquinolone as clinical or radiological features are not adequate to (moxifloxacin or levofloxacin) or a β-lactam (e.g., determine the aetiological agent, and due to the delay in amoxicillin, amoxicillin-clavulanate or cefuroxime) microbiological diagnosis these have to be administered plus a macrolide. For patients requiring admission to empirically. Although this is an extremely useful strategy intensive care, a β-lactam plus azithromycin or β-lactam at the early stage of treatment it is important to move to plus a respiratory fluoroquinolone, with a respiratory definitive less broad-spectrum treatment once a culprit fluoroquinolone plus aztreonam are recommended for pathogen has been identified to limit the emergence penicillin allergic individuals. The British Thoracic of antibiotic-resistant bacteria. Another important Society (5) recommends an oral β-lactam (amoxicillin is consideration in the treatment of CAP is the route of preferred) or doxycycline or clarithromycin for those with © Annals of Research Hospitals. All rights reserved. arh.amegroups.com Ann Res Hosp 2017;1:11 Page 2 of 5 Annals of Research Hospitals, 2017 low illness severity (CURB-65 =0–1), a β-lactam (oral important to note that <5% and <50% of patients received amoxicillin or intravenous benzylpenicillin) plus a macrolide macrolide monotherapy or combination treatment with (clarithromycin is preferred) or doxycycline or respiratory a β-lactam and macrolide (19). Nevertheless, with the fluoroquinolone for those with moderate illness severity changing epidemiology of respiratory pathogen resistance (CURB-65 =2) and intravenous amoxicillin-clavulanate patterns there is great need to develop novel antibiotics to plus a macrolide or intravenous benzylpenicillin plus either treat bacterial CAP. levofloxacin or ciprofloxacin for those with high illness More recently solithromycin, a fourth generation severity (CURB-65 =3–5). Fluoroquinolone monotherapy antibacterial macrolide and first fluoroketolide, was is useful in the treatment of CAP (6,7), however it is developed. The novel chemistry, pharmacokinetics and probably best reserved for those with low illness severity (8) pharmacodynamics of this drug are described in detail or in those where L. pneumophila pneumonia is diagnosed. elsewhere (20,21) and is beyond the scope of this article. Furthermore, the combination of a fluoroquinolone with Solithromycin, available as both an oral and intravenous a β-lactam is advocated, but studies suggest that mortality preparation, is administered once daily and covers the same is worse compared to when a β-lactam and macrolide pathogens as other macrolides, but has the added advantage combination is used (7-9). The empirical use of a macrolide of being bactericidal rather than just bacteriostatic and is together with a β-lactam antibiotic in CAP is justified by effective against bacteria which are resistant against current potentially 20% of CAP being caused by atypical pathogens macrolides. In a study where 38% of S. pneumoniae isolates (L. pneumophila, C. pneumoniae and M. pneumoniae) (3) were resistant to azithromycin, 98.9% and 100% of isolates and results in improved clinical outcomes even in the were inhibited by solithromycin at MIC values of ≤0.25 and presence of drug resistant pathogens (8,10-12). ≤1 mg/L, respectively (13). Solithromycin also inhibited In the last decade, in certain geographical regions, due to 85.3% of methicillin-sensitive Staphylococcus aureus isolates the abundant use of antibiotics there has been an increase in of which only 58.7% were sensitive to azithromycin. antibiotic resistant respiratory pathogens. Of concern is the Additionally, in healthy subjects solithromycin doesn’t increase in penicillin and macrolide-resistant S. pneumoniae significantly affect the QT interval (20,22), which is a since this is the most commonly isolated pathogen. A concern with macrolide use, such as azithromycin, and recent study of 1,713 S. pneumoniae isolates from four fluoroquinolones, such as moxifloxacin, and it does not continents found that only 61.5% and 62.2% were sensitive appear to have the side effect profile that was seen with to penicillin and azithromycin, respectively (13). The telithromycin, a third generation macrolide, which due to SENTRY antimicrobial surveillance program reported cases of drug-induced severe hepatic failure is no longer that in the United States the proportion of erythromycin- marketed (20). Another advantage is that solithromycin is resistant S. pneumoniae in 2011 had increased to 55% (14). more anti-inflammatory than currently used macrolides (23), This figure is more alarming in Asia where 73% of S. which is beneficial, considering that immunomodulatory pneumoniae isolates from a prospective surveillance study effects of macrolides is one of the suggested reasons for were erythromycin resistant (15). Although S. pneumoniae improved outcomes in severe CAP when combined with a resistance to penicillin is increasing, β-lactam antibiotics β-lactam even in the absence of high proportions of atypical at appropriate doses are still useful at treating infection pathogens (8,24,25). The potential of this antibiotic to (16,17) and in countries such the UK and Netherlands that attenuate the levels of pro-inflammatory cytokines and have a low proportion of penicillin- and erythromycin- excessive neutrophilic inflammation by inhibiting NFκB resistant S. pneumoniae isolates the use of older generation activity (23) may in the context of CAP lead to less lung antibiotics are recommended. However, macrolide- injury as observed with other potential immunomodulatory resistance is clinically important as there is evidence from a therapies (26,27), however to date no clinical studies have well conducted prospective study showing that macrolide- been published looking at the efficacy of solithromycin resistance is associated with treatment failure (18). in severe CAP, in reducing admissions for mechanical However, treatment failure in this context does not appear ventilation or adequately powered to detect differences in to impact on mortality. This is confirmed by a more recent mortality. retrospective study that did not demonstrate any differences In a phase two randomised controlled, double-blind in outcome between hospitalised patients with or without clinical study, solithromycin was compared to levofloxacin macrolide-resistant S. pneumoniae
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