International Journal of Antimicrobial Agents
Volume 36, Issue 1 , Pages 1-13 , July 2010

Patients included in randomised controlled trials do not represent those seen in clinical practice: focus on antimicrobial agents

  • Matthew E. Falagas

      Affiliations

    • Alfa Institute of Biomedical Sciences (AIBS), 9 Neapoleos Street, 151 23 Marousi, Athens, Greece
    • Department of Medicine, Henry Dunant Hospital, Athens, Greece
    • Department of Medicine, Tufts University School of Medicine, Boston, MA, USA
    • Corresponding Author InformationCorresponding author. Tel.: +30 694 611 0000; fax: +30 210 683 9605.
  • ,
  • Evridiki K. Vouloumanou

      Affiliations

    • Alfa Institute of Biomedical Sciences (AIBS), 9 Neapoleos Street, 151 23 Marousi, Athens, Greece
  • ,
  • Konstantinos Sgouros

      Affiliations

    • Alfa Institute of Biomedical Sciences (AIBS), 9 Neapoleos Street, 151 23 Marousi, Athens, Greece
  • ,
  • Stavros Athanasiou

      Affiliations

    • 1st Department of Obstetrics and Gynecology, Athens University School of Medicine, Athens, Greece
  • ,
  • George Peppas

      Affiliations

    • Alfa Institute of Biomedical Sciences (AIBS), 9 Neapoleos Street, 151 23 Marousi, Athens, Greece
  • ,
  • Ilias I. Siempos

      Affiliations

    • Alfa Institute of Biomedical Sciences (AIBS), 9 Neapoleos Street, 151 23 Marousi, Athens, Greece

References 

  1. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342:1887–1892
  2. Rosenberg W, Donald A. Evidence based medicine: an approach to clinical problem-solving. BMJ. 1995;310:1122–1126
  3. Fragoulis KN, Michalopoulos A, Falagas ME. Open-access world wide web resources on sepsis. Clin Infect Dis. 2008;47:588
  4. Siempos II, Fragoulis KN, Falagas ME. World Wide Web resources on control of nosocomial infections. Crit Care. 2007;11:101
  5. Siempos II, Dimopoulos G, Falagas ME. Meta-analyses on the prevention and treatment of respiratory tract infections. Infect Dis Clin North Am. 2009;23:331–353
  6. Kollef MH, Afessa B, Anzueto A, Veremakis C, Kerr KM, Margolis BD, et al. Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial. JAMA. 2008;300:805–813
  7. Karageorgopoulos DE, Valkimadi PE, Kapaskelis A, Rafailidis PI, Falagas ME. Short versus long duration of antibiotic therapy for bacterial meningitis: a meta-analysis of randomised controlled trials in children. Arch Dis Child. 2009;94:607–614
  8. Conde MB, Efron A, Loredo C, De Souza GR, Graça NP, Cezar MC, et al. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial. Lancet. 2009;373:1183–1189
  9. Dworkin RH, Barbano RL, Tyring SK, Betts RF, McDermott MP, Pennella-Vaughan J, et al. A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster. Pain. 2009;142:209–217
  10. Ermers MJ, Rovers MM, van Woensel JB, Kimpen JL, Bont LJ. The effect of high dose inhaled corticosteroids on wheeze in infants after respiratory syncytial virus infection: randomised double blind placebo controlled trial. BMJ. 2009;338:b897
  11. Euba G, Murillo O, Fernández-Sabé N, Mascaró J, Cabo J, Pérez A, et al. Long-term follow-up trial of oral rifampin–cotrimoxazole combination versus intravenous cloxacillin in treatment of chronic staphylococcal osteomyelitis. Antimicrob Agents Chemother. 2009;53:2672–2676
  12. Plint AC, Johnson DW, Patel H, Wiebe N, Correll R, Brant R, et al. Epinephrine and dexamethasone in children with bronchiolitis. N Engl J Med. 2009;360:2079–2089
  13. Rehm S, Campion M, Katz DE, Russo R, Boucher HW. Community-based outpatient parenteral antimicrobial therapy (CoPAT) for Staphylococcus aureus bacteraemia with or without infective endocarditis: analysis of the randomized trial comparing daptomycin with standard therapy. J Antimicrob Chemother. 2009;63:1034–1042
  14. Pertel PE, Eisenstein BI, Link AS, Donfrid B, Biermann EJ, Bernardo P, et al. The efficacy and safety of daptomycin vs. vancomycin for the treatment of cellulitis and erysipelas. Int J Clin Pract. 2009;63:368–375
  15. Pareek A, Pednekar S, Prasad HB, Salagre S, Chandurkar N. Randomized, multicentre, comparative clinical evaluation of cefuroxime–sulbactam versus amoxicillin–clavulanic acid therapy in the treatment of lower respiratory tract infections. J Int Med Res. 2008;36:1293–1304
  16. Desrosiers M, Ferguson B, Klossek JM, Drugeon H, Mosges R. Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin–clavulanate in the treatment of acute bacterial sinusitis. Curr Med Res Opin. 2008;24:1691–1702
  17. Lucasti C, Jasovich A, Umeh O, Jiang J, Kaniga K, Friedland I. Efficacy and tolerability of IV doripenem versus meropenem in adults with complicated intra-abdominal infection: a phase III, prospective, multicenter, randomized, double-blind, noninferiority study. Clin Ther. 2008;30:868–883
  18. Martinez RC, Franceschini SA, Patta MC, Quintana SM, Candido RC, Ferreira JC, et al. Improved treatment of vulvovaginal candidiasis with fluconazole plus probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14. Lett Appl Microbiol. 2009;48:269–274
  19. Noel GJ, Blumer JL, Pichichero ME, Hedrick JA, Schwartz RH, Balis DA, et al. A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media. Pediatr Infect Dis J. 2008;27:483–489
  20. Pappas PG, Rotstein CM, Betts RF, Nucci M, Talwar D, De Waele JJ, et al. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2007;45:883–893
  21. Réa-Neto A, Niederman M, Lobo SM, Schroeder E, Lee M, Kaniga K, et al. Efficacy and safety of doripenem versus piperacillin/tazobactam in nosocomial pneumonia: a randomized, open-label, multicenter study. Curr Med Res Opin. 2008;24:2113–2126
  22. Talbot GH, Thye D, Das A, Ge Y. Phase 2 study of ceftaroline versus standard therapy in treatment of complicated skin and skin structure infections. Antimicrob Agents Chemother. 2007;51:3612–3616
  23. Malangoni MA, Song J, Herrington J, Choudhri S, Pertel P. Randomized controlled trial of moxifloxacin compared with piperacillin–tazobactam and amoxicillin–clavulanate for the treatment of complicated intra-abdominal infections. Ann Surg. 2006;244:204–211
  24. Finch R, Schürmann D, Collins O, Kubin R, McGivern J, Bobbaers H, 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
  25. Sher LD, McAdoo MA, Bettis RB, Turner MA, Li NF, Pierce PF. A multicenter, randomized, investigator-blinded study of 5- and 10-day gatifloxacin versus 10-day amoxicillin/clavulanate in patients with acute bacterial sinusitis. Clin Ther. 2002;24:269–281
  26. Alvarez-Lerma F, Insausti-Ordeñana J, Jordá-Marcos R, Maraví-Poma E, Torres-Martí A, Nava J, et al. Efficacy and tolerability of piperacillin/tazobactam versus ceftazidime in association with amikacin for treating nosocomial pneumonia in intensive care patients: a prospective randomized multicenter trial. Intensive Care Med. 2001;27:493–502
  27. Siami G, Christou N, Eiseman I, Tack KJ. Clinafloxacin versus piperacillin–tazobactam in treatment of patients with severe skin and soft tissue infections. Antimicrob Agents Chemother. 2001;45:525–531
  28. File T, Schlemmer B, Garau J, Lode H, Lynch S, Young C. Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. The 070 Clinical Study group. J Chemother. 2000;12:314–325
  29. Schouenborg P, Gerdes N, Rasmussen H, Wickers-Nielsen N, Mathiassen E. Azithromycin versus pivampicillin in the treatment of acute exacerbations of chronic bronchitis: a single-blind, double-dummy, multicentre study. J Int Med Res. 2000;28:101–110
  30. Cohn SM, Lipsett PA, Buchman TG, Cheadle WG, Milsom JW, O’Marro S, et al. Comparison of intravenous/oral ciprofloxacin plus metronidazole versus piperacillin/tazobactam in the treatment of complicated intraabdominal infections. Ann Surg. 2000;232:254–262
  31. Joshi M, Bernstein J, Solomkin J, Wester BA, Kuye O. Piperacillin/tazobactam plus tobramycin versus ceftazidime plus tobramycin for the treatment of patients with nosocomial lower respiratory tract infection. Piperacillin/tazobactam Nosocomial Pneumonia Study Group. J Antimicrob Chemother. 1999;43:389–397
  32. Brun-Buisson C, Sollet JP, Schweich H, Briere S, Petit C. Treatment of ventilator-associated pneumonia with piperacillin–tazobactam/amikacin versus ceftazidime/amikacin: a multicenter, randomized controlled trial. VAP Study Group. Clin Infect Dis. 1998;26:346–354
  33. Scheinin H, Havia T, Pekkala E, Huovinen P, Klossner J, Lehto H, et al. Aspoxicillin versus piperacillin in severe abdominal infections—a comparative phase III study. J Antimicrob Chemother. 1994;34:813–817
  34. Sweet RL, Roy S, Faro S, O’Brien WF, Sanfilippo JS, Seidlin M. Piperacillin and tazobactam versus clindamycin and gentamicin in the treatment of hospitalized women with pelvic infection. The Piperacillin/tazobactam Study Group. Obstet Gynecol. 1994;83:280–286
  35. Klietmann W, Cesana M, Rondel RK, Focht J. Double-blind, comparative study of rufloxacin once daily versus amoxicillin three times a day in treatment of outpatients with exacerbations of chronic bronchitis. Antimicrob Agents Chemother. 1993;37:2298–2306
  36. Brambilla C, Kastanakis S, Knight S, Cunningham K. Cefuroxime and cefuroxime axetil versus amoxicillin plus clavulanic acid in the treatment of lower respiratory tract infections. Eur J Clin Microbiol Infect Dis. 1992;11:118–124
  37. Lousbergh D, Jochems G, Everaert L, Puttemans M. Roxithromycin versus amoxicillin–clavulanic acid in the treatment of respiratory tract infections. Diagn Microbiol Infect Dis. 1992;15(4 Suppl.):91S–95S
  38. Sackett DL, Rosenberg WM. The need for evidence-based medicine. J R Soc Med. 1995;88:620–624
  39. Feinstein AR, Horwitz RI. Problems in the ‘evidence’ of ‘evidence-based medicine’. Am J Med. 1997;103:529–535
  40. Jacobson LD, Edwards AG, Granier SK, Butler CC. Evidence-based medicine and general practice. Br J Gen Pract. 1997;47:449–452
  41. Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C. Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy. 1999;4:112–121
  42. Falagas ME, Rafailidis PI, Rosmarakis ES. Arrhythmias associated with fluoroquinolone therapy. Int J Antimicrob Agents. 2007;29:374–379
  43. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969–2002: the importance of reporting suspected reactions. Arch Intern Med. 2005;165:1363–1369
  44. Bottone FG, Barry WT. Postmarketing surveillance of serious adverse events associated with the use of rofecoxib from 1999–2002. Curr Med Res Opin. 2009;25:1535–1550
  45. Garfield FB, Caro JJ. Postmarketing studies: benefits and risks. Value Health. 1999;2:295–307
  46. Garg AX, Mamdani M, Juurlink DN, van Walraven C. Identifying individuals with a reduced GFR using ambulatory laboratory database surveillance. J Am Soc Nephrol. 2005;16:1433–1439
  47. Garg AX, Papaioannou A, Ferko N, Campbell G, Clarke JA, Ray JG. Estimating the prevalence of renal insufficiency in seniors requiring long-term care. Kidney Int. 2004;65:649–653
  48. Ryan TP, Sloand JA, Winters PC, Corsetti JP, Fisher SG. Chronic kidney disease prevalence and rate of diagnosis. Am J Med. 2007;120:981–986
  49. Clark JM, Brancati FL, Diehl AM. The prevalence and etiology of elevated aminotransferase levels in the United States. Am J Gastroenterol. 2003;98:960–967
  50. Freedman LS, Simon R, Foulkes MA, Friedman L, Geller NL, Gordon DJ, et al. Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993—the perspective of NIH clinical trialists. Control Clin Trials. 1995;16:277–285
  51. Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA. 1992;268:1417–1422
  52. Hall WD. Representation of Blacks, women, and the very elderly (aged ≥80) in 28 major randomized clinical trials. Ethn Dis. 1999;9:333–340
  53. Hutchins LF, Unger JM, Crowley JJ, Coltman CA, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341:2061–2067
  54. Bennett JC. Inclusion of women in clinical trials—policies for population subgroups. N Engl J Med. 1993;329:288–292
  55. Iannini PB. The safety profile of moxifloxacin and other fluoroquinolones in special patient populations. Curr Med Res Opin. 2007;23:1403–1413
  56. Walson PD. Therapeutic drug monitoring in special populations. Clin Chem. 1998;44:415–419
  57. Yoshikawa K, Davies A. Safety of ProHance in special populations. Eur Radiol. 1997;7(Suppl. 5):246–250

PII: S0924-8579(10)00153-6

doi: 10.1016/j.ijantimicag.2010.03.020

International Journal of Antimicrobial Agents
Volume 36, Issue 1 , Pages 1-13 , July 2010