Efficacy and safety of oral solithromycin versus oral moxifloxacin for treatment of community-acquired bacterial pneumonia: A global, double-blind, multicentre, randomised, active-controlled, non-inferiority trial (SOLITAIRE-ORAL)

The Lancet Infectious Diseases

Volumn 16, Issue 4, 2016, Pages 421-430

  Barrera, Carlos M ^a   Mykietiuk, Analia ^b   Metev, Hristo ^c   Nitu, Mimi Floarea ^d   Karimjee, Najumuddin ^e   Doreski, Pablo Alexis ^f   Mitha, Ismail ^g   Tanaseanu, Cristina Mihaela ^h   Molina, Joseph McDermott ⁱ   Antonovsky, Yuri ^j   Van Rensburg, Dirkie Johanna ^k   Rowe, Brian H ^l   Flores Figueroa, Jose ^m   Rewerska, Barbara ⁿ   Clark, Kay ^o   Keedy, Kara ^o   Sheets, Amanda ^o   Scott, Drusilla ^o   Horwith, Gary ^o   Das, Anita F ^p   Jamieson, Brian ^o   Fernandes, Prabhavathi ^o   Oldach, David ^o   more..

^a AandL Clinical Research   (United States)

^b Instituto Medico Platense   (Argentina)

^c Specialized Hospital for Active Treatment of Pneumo Phthisiatric Diseases   (Bulgaria)

^d Dr Victor Babes Clinical Hospital for Infectious Diseases and Pneumophthisiology ^*  (Romania)

^e Delta County Medical Center   (United States)

^f Centro Médico Seremas   (Argentina)

^g World Wide Clinical Trials   (South Africa)

^h St Pantelimon Clinical Emergency Hospital   (Romania)

ⁱ HOSPITAL LUIS VERNAZA   (Ecuador)

^j Clinical Hospital #23 Medsantrud   (Russian Federation)

^k Park Medical Center   (South Africa)

^l UNIVERSITY OF ALBERTA   (Canada)

^m JM Research   (United States)

ⁿ Good Doctor Specialist Outpatient Clinics   (Poland)

^o Cempra Pharmaceuticals   (United States)

^p Das Consulting   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

MOXIFLOXACIN; PLACEBO; SOLITHROMYCIN; ANTIINFECTIVE AGENT; MACROLIDE; QUINOLONE DERIVATIVE; TRIAZOLE DERIVATIVE;

ADULT; AGED; ARTICLE; ASTHMA; CHRONIC OBSTRUCTIVE LUNG DISEASE; COMMUNITY ACQUIRED PNEUMONIA; CONTROLLED STUDY; COUGHING; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; EUROPE; FEMALE; HEADACHE; HUMAN; INTENTION TO TREAT ANALYSIS; INTERNET; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MULTICENTER STUDY; NAUSEA; OUTCOMES RESEARCH; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOUTH AFRICA; SOUTH AND CENTRAL AMERICA; SPUTUM; THORAX PAIN; VOMITING; WESTERN HEMISPHERE; ADOLESCENT; CLINICAL TRIAL; COMMUNITY-ACQUIRED INFECTIONS; MIDDLE AGED; NORTH AMERICA; PHASE 3 CLINICAL TRIAL; PNEUMONIA, BACTERIAL; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; COMMUNITY-ACQUIRED INFECTIONS; DOUBLE-BLIND METHOD; EUROPE; FEMALE; FLUOROQUINOLONES; HUMANS; LATIN AMERICA; MACROLIDES; MALE; MIDDLE AGED; NORTH AMERICA; PNEUMONIA, BACTERIAL; SOUTH AFRICA; TRIAZOLES; YOUNG ADULT;

EID: 84961396906     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(16)00017-7     Document Type: Article

References (44)

1. Welte T, Torres A, Nathwani D Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax 2012, 67:71-79.
2. File TM, Low DE, Eckburg PB, et al. FOCUS 1: a randomized, double-blinded, multicentre phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother 2011, 66(suppl 3):iii19-iii32.
3. Low DE, File TM, Eckburg PB, et al. Focus 2: a randomized, double-blinded, multicenter, phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother 2011, 66(suppl 3):iii33-iii44.
4. Musher DM, Thorner AR Community-acquired pneumonia. N Engl J Med 2014, 371:1619-1628.
5. Jain S, Self WH, Wunderlink RG, et al. Community acquired pneumonia requiring hospitalization among US adults. N Engl J Med 2015, 373:415-427.
6. Holter JC, Muller F, Bjorang O, et al. Etiology of community-acquired pneumonia and diagnostic yields of microbiological methods: a 3-year prospective study. BMC Infect Dis 2015, 15:64.
7. Woodhead M, Blasi F, Ewig S, et al. Joint Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases. Guidelines for the management of adult lower respiratory tract infections-full version. Clin Microbiol Infect 2011, 17(suppl 6):E1-59.
8. 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.
9. Jones RN, Sader HS, Mendes RE, Flamm RK Update on antimicrobial susceptibility trends among Streptococcus pneumoniae in the United States: report of ceftaroline activity from the SENTRY Antimicrobial Surveillance Program (1998-2011). Diagn Microbiol Infect Dis 2013, 75:107-109.
10. Morrissey I, Fernandes P, Lemos B, Hawser SP. Activity of solithromycin and comparators against streptococci isolated from respiratory samples collected in 2012-13. 24th European Congress of Clinical Microbiology and Infectious Diseases; Barcelona, Spain; May 10-14, 2014. P1584.
11. Loo VG, Poirier L, Miller MA, et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med 2005, 353:2442-2449.
12. Pepin J, Saheb N, Coulombe MA, et al. Emergence of fluoroquinolones as the predominant risk factor for Clostridium difficile-associated diarrhea: a cohort study during an epidemic in Quebec. Clin Infect Dis 2005, 41:1254-1260.
13. Toth A, Kocsis B, Damjanova I, et al. Fitness cost associated with resistance to fluoroquinolones is diverse across clones of Klebsiella pneumoniae and may select for CTX-M-15 type extended-spectrum β-lactamase. Eur J Clin Microbiol Infect Dis 2014, 33:837-843.
14. Webber MA, Cicci V, Whitehead R, et al. Clinically relevant mutant DNA gyrase alters supercoiling, changes the transcriptome, and confers multidrug resistance. MBio 2013, 4:e00273-e00313.
15. Stahlmann R, Lode HM Risks associated with the therapeutic use of fluoroquinolones. Expert Opin Drug Saf 2013, 12:497-505.
16. Etminan M, Brophy JM, Samii A Oral fluoroquinolone use and risk of peripheral neuropathy: a pharmacoepidemiologic study. Neurology 2014, 83:1261-1263.
17. File TM, Marrie TJ Does empiric therapy for atypical pathogens improve outcomes for patients with CAP?. Infect Dis Clin North Am 2013, 27:99-114.
18. Postma DF, vanWerkhoven CH, van Elden LJR, et al. Antibiotic treatment strategies for community-acquired pneumonia in adults. N Engl J Med 2015, 372:1312-1323.
19. Garin N, Genne D, Carballo S, et al. β-lactam monotherapy vs β-lactam-macrolide combination treatment in moderately severe community acquired pneumonia: a randomized noninferiority trial. JAMA Intern Med 2014, 174:1894-1901.
20. Lee JS, Fine MJ The debate on antibiotic therapy for patients hospitalized for pneumonia. Where should we go from here?. JAMA Intern Med 2014, 174:1901-1903.
21. Mandell LA, Waterer GW Empirical therapy of community acquired pneumonia: advancing evidence or just more doubt. JAMA 2015, 314:396-397.
22. Farrell DJ, Sader HS, Castanheira M, Biedenbach DJ, Rhomberg PR, Jones RN 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.
23. McGhee P, Clark C, Kosowska-Shick KM, et al. In vitro activity of CEM-101 against Streptococcus pneumoniae and Streptococcus pyogenes with defined macrolide resistance mechanisms. Antimicrob Agents Chemother 2010, 54:230-238.
24. Waites KB, Crabb DM, Duffy LB Comparative in vitro susceptibilities of human mycoplasmas and ureaplasmas to a new investigational ketolide, CEM-101. Antimicrob Agents Chemother 2009, 53:2139-2141.
25. Putnam SD, Sader HS, Farrell DJ, Biedenbach DJ, Castanheira M Antimicrobial characterisation of solithromycin (CEM-101), a novel fluoroketolide: activity against staphylococci and enterococci. Int J Antimicrob Agents 2011, 37:39-45.
26. 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.
27. Kobayashi Y, Wada H, Rossios C, et al. A novel macrolide solithromycin exerts superior anti-inflammatory effect via NF-αB inhibition. J Pharmacol Exp Ther 2013, 345:76-84.
28. 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.
29. Guidance for industry. Community-acquired bacterial pneumonia: developing drugs for treatment. Draft guidance US Food and Drug Administration, (accessed Sept 12, 2015). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm123686.pdf.
30. Fine MJ, Stone RA, Singer DE, et al. Processes and outcomes of care for patients with community-acquired pneumonia. Results from the Pneumonia Patient Outcomes Research Team (PORT) Cohort Study. Arch Intern Med 1999, 159:970-980.
31. Chalmers JD, Singanayagam A, Akram AR, et al. Severity assessment tools for predicting mortality in hospitalized patients with community-acquired pneumonia. Systematic review and meta-analysis. Thorax 2010, 65:78-83.
32. 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.
33. Rodvold KA, Gotfried MH, Still JG, Clark K, Fernandes P 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.
34. Lim WS, van der Eerden MM, Laing R, et al. Defining community acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax 2003, 58:377-382.
35. American College of Chest Physicians/Society of Critical Care Medicine consensus conference: definitions of sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 1992, 20:864-874.
36. Guidance for industry: non-inferiority clinical trials. Draft guidance. March US Food and Drug Administration, (accessed Sept 12, 2015). http://www.fda.gov/downloads/Drugs/--/Guidances/UCM202140.pdf.
37. Finch R, Schurmann D, Collins O, et al. Randomized controlled trial of sequential intravenous (i.v.) and oral moxifloxacin compared with sequential i.v. and oral co-amoxiclav with or without clarithromycin in patients with community-acquired pneumonia requiring initial parenteral treatment. Antimicrob Agents Chemother 2002, 46:1746-1754.
38. Bordon J, Peyrani P, Brock G, et al. The presence of pneumococcal bacteremia does not influence clinical outcomes in patients with community acquired pneumonia. Results from the community-acquired pneumonia organization (CAPO) international cohort study. Chest 2008, 133:618-624.
39. Ramirez J, Bordon J Early switch from intravenous to oral antibiotics in hospitalized patients with bacteremic community-acquired Streptococcus pneumoniae pneumonia. Arch Intern Med 2001, 161:848-850.
40. Torres A, Blasi F, Peetermans WE, Viegi G, Welte T The aetiology and antibiotic management of community-acquired pneumonia in adults in Eutope: a literature review. Eur J Clin Microbiol Infect Dis 2014, 33:1065-1079.
41. Woodhead M, Blasi F, Ewig S, et al. Guidelines for the management of adult lower respiratory tract infections-summary. Clin Microbiol Infect 2011, 17(suppl 6):E1-59.
42. Kannan TR, Baseman J ADP-ribosylating and vacuolating cytotoxin of Mycoplasma pneumoniae represents unique virulence determinant among bacterial pathogens. Proc Natl Acad Sci USA 2006, 103:6724-6729.
43. Kannan TR, Hardy RD, Coalson JJ, et al. Fatal outcomes in family transmission of Mycoplasma pneumoniae. Clin Infect Dis 2012, 54:225-231.
44. Hastings DL, Harrington KJ, Kutty PK, et al. Mycoplasma pneumoniae outbreak in a long-term care facility-Nebraska, 2014. Morb Mortal Wkly Rep 2015, 64:296-299.