348
Views
16
CrossRef citations to date
0
Altmetric
Reviews

The role of solithromycin in the management of bacterial community-acquired pneumonia

&
Pages 311-324 | Received 04 Nov 2015, Accepted 04 Jan 2016, Published online: 05 Feb 2016

References

  • GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385:117–171.
  • Drijkoningen JJC, Rohde GGU. Pneumococcal infection in adults: burden of disease. Clin Microbiol Infect. 2014;20(Suppl 5):45–51.
  • Wallihan R, Ramilo O. Community-acquired pneumonia in children: current challenges and future directions. J Infect. 2014;69(Suppl 1):S87–S90.
  • Jackson ML, Neuzil KM, Thompson WW, et al. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004;39:1642–1650.
  • Prina E, Ranzani OT, Torres A. Community-acquired pneumonia. Lancet. 2015;386:1097–1108.
  • Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax. 2012;67:71–79.
  • Aliberti S, Kaye KS. The changing microbiologic epidemiology of community-acquired pneumonia. Postgrad Med. 2013;125:31–42.
  • Restrepo MI, Faverio P, Anzueto A. Long-term prognosis in community-acquired pneumonia. Curr Opin Infect Dis. 2013;26:151–158.
  • Torres A, Blasi F, Peetermans WE, et al. The aetiology and antibiotic management of community-acquired pneumonia in adults in Europe: a literature review. Eur J Clin Microbiol Infect Dis. 2014;33:1065–1079.
  • Rozenbaum MH, Pechlivanoglou P, Van Der Werf TS, et al. The role of Streptococcus pneumoniae in community-acquired pneumonia among adults in Europe: a meta-analysis. Eur J Clin Microbiol Infect Dis. 2013;32:305–316.
  • Klapdor B, Ewig S, Pletz MW, et al. Community-acquired pneumonia in younger patients is an entity on its own. Eur Respir J. 2012;39:1156–1161.
  • Ewig S, Klapdor B, Pletz MW, et al. Nursing-home-acquired pneumonia in Germany: an 8-year prospective multicentre study. Thorax. 2012;67:132–138.
  • Peto L, Nadjm B, Horby P, et al. The bacterial aetiology of adult community-acquired pneumonia in Asia: a systematic review. Trans R Soc Trop Med Hyg. 2014;108:326–337.
  • Niederman MS. Community-Acquired Pneumonia. Ann Intern Med. 2015;163:ITC1.
  • Lee YR, Houngue C, Hall RG. Treatment of community-acquired pneumonia. Expert Rev Anti Infect Ther. 2015;13:1109–1121.
  • Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(Suppl 2):S27–S72.
  • Woodhead M, Blasi F, Ewig S, et al. Guidelines for the management of adult lower respiratory tract infections–full version. Clin Microbiol Infect. 2011;17(Suppl 6):E1E59.
  • Lim WS, Smith DL, Wise MP, et al. British Thoracic Society community acquired pneumonia guideline and the NICE pneumonia guideline: how they fit together. BMJ Open Respir Res. 2015;2:e000091.
  • Mpenge MA, MacGowan AP. Ceftaroline in the management of complicated skin and soft tissue infections and community acquired pneumonia. Ther Clin Risk Manag. 2015;11:565–579.
  • Liapikou A, Cilloniz C, Torres A. Ceftobiprole for the treatment of pneumonia: a European perspective. Drug Des Devel Ther. 2015;9:4565–4572.
  • Van Bambeke F. Macrolides and Ketolides. In: Vinks A, Derendorf H, Mouton JW, editors. Fundamentals of antimicrobial pharmacokinetics and pharmacodynamics. New-York (NY): Springer; 2014. p. 257–278.
  • Kim SH, Song JH, Chung DR, et al. Changing trends in antimicrobial resistance and serotypes of Streptococcus pneumoniae isolates in Asian countries: an Asian Network for Surveillance of Resistant Pathogens (ANSORP) study. Antimicrob Agents Chemother. 2012;56:1418–1426.
  • Bielicki JA, Lundin R, Sharland M. Antibiotic resistance prevalence in routine bloodstream isolates from children’s hospitals varies substantially from adult surveillance data in Europe. Pediatr Infect Dis J. 2015;34:734–741.
  • Pfaller MA, Farrell DJ, Sader HS, et al. AWARE Ceftaroline Surveillance Program (2008-2010): trends in resistance patterns among Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis in the United States. Clin Infect Dis. 2012;55(Suppl 3):S187S193.
  • Wierzbowski AK, Karlowsky JA, Adam HJ, et al. Evolution and molecular characterization of macrolide-resistant Streptococcus pneumoniae in Canada between 1998 and 2008. J Antimicrob Chemother. 2014;69:59–66.
  • Diaz MH, Benitez AJ, Winchell JM. Investigations of Mycoplasma pneumoniae infections in the United States: trends in molecular typing and macrolide resistance from 2006 to 2013. J Clin Microbiol. 2015;53:124–130.
  • Liu Y, Ye X, Zhang H, et al. Antimicrobial susceptibility of Mycoplasma pneumoniae isolates and molecular analysis of macrolide-resistant strains from Shanghai, China. Antimicrob Agents Chemother. 2009;53:2160–2162.
  • Van Bambeke F, Reinert RR, Appelbaum PC, et al. Multidrug-resistant Streptococcus pneumoniae infections: current and future therapeutic options. Drugs. 2007;67:2355–2382.
  • Pai MP, Momary KM, Rodvold KA. Antibiotic drug interactions. Med Clin North Am. 2006;90:1223–1255.
  • Abo-Salem E, Fowler JC, Attari M, et al. Antibiotic-induced cardiac arrhythmias. Cardiovasc Ther. 2014;32:19–25.
  • Andrade RJ, Tulkens PM. Hepatic safety of antibiotics used in primary care. J Antimicrob Chemother. 2011;66:1431–1446.
  • Broad J, Sanger GJ. The antibiotic azithromycin is a motilin receptor agonist in human stomach: comparison with erythromycin. Br J Pharmacol. 2013;168:1859–1867.
  • McFarlane A, Sligl W. The value of macrolide-based regimens for community-acquired Pneumonia. Curr Infect Dis Rep. 2015;17:50.
  • Skalsky K, Yahav D, Lador A, et al. Macrolides vs. quinolones for community-acquired pneumonia: meta-analysis of randomized controlled trials. Clin Microbiol Infect. 2013;19:370–378.
  • Cilloniz C, Albert RK, Liapikou A, et al. The effect of macrolide resistance on the presentation and outcome of patients hospitalized for streptococcus pneumoniae Pneumonia. Am J Respir Crit Care Med. 2015;191:1265–1272.
  • Kovaleva A, Remmelts HHF, Rijkers GT, et al. Immunomodulatory effects of macrolides during community-acquired pneumonia: a literature review. J Antimicrob Chemother. 2012;67:530–540.
  • Emmet O’Brien M, Restrepo MI, Martin-Loeches I. Update on the combination effect of macrolide antibiotics in community-acquired pneumonia. Respir Investig. 2015;53:201–209.
  • Garin N, Genne D, Carballo S, et al. beta-Lactam monotherapy vs beta-lactam-macrolide combination treatment in moderately severe community-acquired pneumonia: a randomized noninferiority trial. JAMA Intern Med. 2014;174:1894–1901.
  • Ambroggio L, Test M, Metlay JP, et al. Beta-lactam versus beta-lactam/macrolide therapy in pediatric outpatient pneumonia. Pediatr Pulmonol. 2015 Sep 14. doi:10.1002/ppul.23312. [Epub ahead of print].
  • Van Bambeke F. Renaissance of antibiotics against difficult infections: Focus on oritavancin and new ketolides and quinolones. Ann Med. 2014;46:512–529.
  • Van Bambeke F, Harms JM, Van Laethem Y, et al. Ketolides: pharmacological profile and rational positioning in the treatment of respiratory tract infections. Expert Opin Pharmacother. 2008;9:267–283.
  • Bertrand D, Bertrand S, Neveu E, et al. Molecular characterization of off-target activities of telithromycin: a potential role for nicotinic acetylcholine receptors. Antimicrob Agents Chemother. 2010;54:5399–5402.
  • Llano-Sotelo B, Dunkle J, Klepacki D, et al. Binding and action of CEM-101, a new fluoroketolide antibiotic that inhibits protein synthesis. Antimicrob Agents Chemother. 2010;54:4961–4970.
  • Rodgers W, Frazier AD, Champney WS. Solithromycin inhibition of protein synthesis and ribosome biogenesis in Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae. Antimicrob Agents Chemother. 2013;57:1632–1637.
  • Gupta P, Kannan K, Mankin AS, et al. Regulation of gene expression by macrolide-induced ribosomal frameshifting. Mol Cell. 2013;52:629–642.
  • Farrell DJ, Sader HS, Castanheira M, et al. Antimicrobial characterisation of CEM-101 activity against respiratory tract pathogens, including multidrug-resistant pneumococcal serogroup 19A isolates. Int J Antimicrob Agents. 2010;35:537–543.
  • Farrell DJ, Mendes RE, Jones RN. Antimicrobial activity of solithromycin against serotyped macrolide-resistant Streptococcus pneumoniae isolates collected from U.S. medical centers in 2012. Antimicrob Agents Chemother. 2015;59:2432–2434.
  • Putnam SD, Sader HS, Farrell DJ, et al. Antimicrobial characterisation of solithromycin (CEM-101), a novel fluoroketolide: activity against staphylococci and enterococci. Int J Antimicrob Agents. 2011;37:39–45.
  • Roblin PM, Kohlhoff SA, Parker C, et al. In vitro activity of CEM-101, a new fluoroketolide antibiotic, against Chlamydia trachomatis and Chlamydia (Chlamydophila) pneumoniae. Antimicrob Agents Chemother. 2010;54:1358–1359.
  • Mallegol J, Fernandes P, Melano RG, et al. Antimicrobial activity of solithromycin against clinical isolates of Legionella pneumophila serogroup 1. Antimicrob Agents Chemother. 2014;58:909–915.
  • Farrell DJ, Flamm RK, Sader HS, et al. Activity of solithromycin tested against pathogens associated with community-acquired bacterial pneumonia: Global surveillance results for 2014. 55th Interescience Conference on Antimicrobial Agents and Chemotherapy (American Society for Microbiology); 2015; September 17–21; San Diego, CA. Poster no. C622.
  • Tulkens PM, Van Bambeke F, Vandevelde NM, et al. In vitro susceptibility of S. pneumoniae to solithromycin (SOL) in collections with an elevated proportion of isolates resistant to levofloxacin (LVX) and moxifloxacin (MXF). 25th European Congress of Clinical Microbiology and Infectious Diseases (European Society of Clinical Microbiology and Infectious Diseases); 2015; April 25–28; Copenhagen. Poster no. EV0153.
  • Magnet S, Morrissey I, Fernandes P, et al. Assessment of the bactericidal activity of solithromycin (CEM-101) against Streptococcus pneumoniae with known macrolide-resistance mechanism and serotype. 55th Interescience Conference on Antimicrobial Agents and Chemotherapy (American Society for Microbiology); 2015; September 17–21; San Diego, CA. Poster no. C550
  • Vandevelde NM, Tulkens PM, Van Bambeke F. Antibiotic activity against naive and induced Streptococcus pneumoniae biofilms in an in vitro pharmacodynamic model. Antimicrob Agents Chemother. 2014;58:1348–1358.
  • Lemaire S, Van Bambeke F, Tulkens PM. Cellular accumulation and pharmacodynamic evaluation of the intracellular activity of CEM-101, a novel fluoroketolide, against Staphylococcus aureus, Listeria monocytogenes, and Legionella pneumophila in human THP-1 macrophages. Antimicrob Agents Chemother. 2009;53:3734–3743.
  • Still JG, Schranz J, Degenhardt TP, et al. Pharmacokinetics of solithromycin (CEM-101) after single or multiple oral doses and effects of food on single-dose bioavailability in healthy adult subjects. Antimicrob Agents Chemother. 2011;55:1997–2003.
  • Rodvold KA, Gotfried MH, Still JG, et al. Comparison of plasma, epithelial lining fluid, and alveolar macrophage concentrations of solithromycin (CEM-101) in healthy adult subjects. Antimicrob Agents Chemother. 2012;56:5076–5081.
  • Okusanya OO, Bhavnani SM, Forrest A, et al. Population Pharmacokinetic (PPK) and Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment (TA) Analyses for Solithromycin (SOL, CEM-101) to Support Intravenous (IV). 52d Interscience Conference on Antimicrobial Agents and Chemotherapy (American Society for Microbiology); 2012; September 9–12; San Francisco, CA. Poster no. A1269.
  • Okusanya OO, Bhavnani SM, Forrest A, et al. Pharmacokinetic-Pharmacodynamic target attainment analysis supporting Solithromycin (CEM-101) Phase 2 dose selection. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (American Society for Microbiology); 2010; September 12–15; Boston, MA. Poster no. A1A692.
  • Schranz J, Clark K, Marion A, et al. A Phase 1 trial to evaluate the safety and pharmacokinetics of single doses of intravenous (IV) solithromycin (CEM-101) in healthy adult subjects. 21th European Congress of Clinical Microbiology and Infectious Diseases (European Society of Microbiology and Infectious Diseases) & 27th International Congress of Chemotherapy (International Society of Chemotherapy); 2011; May 7–10; Milano. Poster no. O95.
  • Jamieson BD, Ciric S, Fernandes P. Safety and pharmacokinetics of solithromycin in subjects with hepatic impairment. Antimicrob Agents Chemother. 2015;59:4379–4386.
  • Andes DR, Okusanya OO, Forrest A, et al. Pharmacokinetic-Pharmacodynamic (PK-PD) analysis of Solithromycin against Streptococcus pneumoniae using data from a murine-lung infection model. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (American Society for Microbiology); 2010; September 12–15; Boston. Poster no. A1A688.
  • Gonzales D, Palazzi D, Bhattacharya-Mithal L, et al. Pharmacokinetics and safety of solithromycin in adolescents with suspected or confirmed bacterial infection. Meeting of the Pediatric Academic Societies Meeting; 2015; April 25–28; San Diego, CA. Poster no. P340.
  • Kobayashi Y, Wada H, Rossios C, et al. A novel macrolide solithromycin exerts superior anti-inflammatory effect via NF-kappaB inhibition. J Pharmacol Exp Ther. 2013;345:76–84.
  • Kobayashi Y, Wada H, Rossios C, et al. A novel macrolide/fluoroketolide, solithromycin (CEM-101), reverses corticosteroid insensitivity via phosphoinositide 3-kinase pathway inhibition. Br J Pharmacol. 2013;169:1024–1034.
  • Darpo B, Philip S, Zhou M, et al. Solithromycin, a 4th generation macrolide and the 1st fluoroketolide, does not prolong the QTc interval: results of a definitive QT study. 25th European Congress of Clinical Microbiology and Infectious Diseases (European Society of Microbiology and Infectious Diseases); 2015; April 25–28; Copenhagen. Poster no. LBEV0081a.
  • Oldach D, Clark K, Schranz J, et al. Randomized, double-blind, multicenter phase 2 study comparing the efficacy and safety of oral solithromycin (CEM-101) to those of oral levofloxacin in the treatment of patients with community-acquired bacterial pneumonia. Antimicrob Agents Chemother. 2013;57:2526–2534.
  • Chochua S, Sheets A, Keedy K, et al. Prevalence of pneumococcal serotypes in adults enrolled in a Phase 3 trial that evaluated the efficacy and safety of oral solithromycin (CEM-101) versus moxifloxacin in adults with CABP. 55th Interescience Conference on Antimicrobial Agents and Chemotherapy (American Society for Microbiology) 2015; September 17–21; San Diego, CA. Poster no. L1274.
  • Oldach D, Metev H, Mykiertiul A, et al. Characterization of Mycoplasma pneumoniae infection and outcomes in the Solitaire-Oral, Global Phase 3 Clinical Trial for Solithromycin. ID Week (Infectious Diseases Society of America) 2012; September 17–21; San Francisco, CA. Poster no. 893
  • Oldach D, Barrera CM, Luna C, et al. Oral solithromycin has a favorable profile versus oral moxifloxacin for treatment of adult community-acquired bacterial pneumonia (CABP) in elderly patients and those with COPD or asthma. 25th Annual Congress of European Respiratory Society (European Respiratory Society); 2015; September 26–30; Amsterdam. Poster no. PA2655.
  • Oldach D, Barrera CM, Metev H, et al. Oral solithromycin versus oral moxifloxacin for treatment of adult community-acquired bacterial pneumonia (CABP): results of the global Phase 3 trial, solitaire oral. American Thoracic Society Conference (American Thoracic Society); 2015; May 15–20; Poster no. A6424.
  • The top 10 causes of death. The World Health Organization [Internet]. Geneva: Media Center- Fact sheets. 2014. [cited 2015 Oct 25]. Available from: http://www.who.int/mediacentre/factsheets/fs310/en/index1.html.
  • Walker CLF, Rudan I, Liu L, et al. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013;381:1405–1416.
  • Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2197–2223.
  • Georgopapadakou NH. The wobbly status of ketolides: where do we stand? Expert Opin Investig Drugs. 2014;23:1313–1319.
  • Echols RM. Understanding the regulatory hurdles for antibacterial drug development in the post-Ketek world. Ann N Y Acad Sci. 2011;1241:153–161.
  • Fernandes P. Investment in antibiotics against pneumonia. Lancet Infect Dis. 2015;15:376.
  • Mushtaq A. Solithromycin to treat community-acquired pneumonia? Lancet Respir Med. 2015;3:429.
  • Head MG, Fitchett JR, Newell ML, et al. Investment in pneumonia and pneumococcal research. Lancet Infect Dis. 2014;14:1037–1038.
  • Van Bambeke F, Tulkens PM. Safety profile of the respiratory fluoroquinolone moxifloxacin: comparison with other fluoroquinolones and other antibacterial classes. Drug Saf. 2009;32:359–378.
  • Carbonnelle S, Lismond A, Van Bambeke F, et al. Analysis of guidelines for treatment of Community acquired pneumonia (CAP) in outpatients. 26th International Conference on Chemotherapy (International Society of Chemotherapy); 2009; June 18–21; Toronto, ON. Poster no. 315

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.