Organization of Clinical Trials: Problems, Controversies, Definitions, and Methodology Related to Infections in Neutropenic Patients
This subject is a rather complicated one since there is very little literature specifically addressing it. In this short review I plan to state my own views while taking into account the Immunocompromised Host Society review article published in 1990 in the Journal of Infectious Diseases and the report by Pater and Weir in the Journal of Clinical Oncology in March 1986 dealing with a critical survey of 21 randomized trials on the therapy of febrile neutropenic patients reviewed by these authors. The third paper of significance is one by Elliott and Pater published in 1988 in Clinical Investigative Medicine dealing with the effect of different measures of outcome on the results of these kinds of studies. Although other literature may be pertinent, I believe these papers address the issues best. Therapeutic approaches in these patients were well summarized in a recent Infectious Diseases Society of America consensus paper (Hughes et al. 1990).
KeywordsNeutropenic Patient Febrile Episode Febrile Neutropenic Patient Unexplained Fever Combination Antibiotic Therapy
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- Pizzo PA, Hathorn JW, Hiemenz J, Browne M, Commers J, Cotton D, Gress J, Longo D, Marshall D, McKnight J, Rubin M, Skelton J, Thaler M, Wesley R (1986) A randomized trial comparing ceftazidime alone with combination antibiotic therapy in cancer patients with fever and neutropenia. N Engl J Med 315: 552–558PubMedCrossRefGoogle Scholar
- Hughes WT, Armstrong D, Bodey GP, Feld R, Mandell GL, Meyers JD, Pizzo PA, Schimpff SC, Shenep JL, Wade JC, Young L, Yow MJ (1990) Guidelines for the use of antimicrobial agents in neutropenic patients with unexplained fever. J Infect Dis 161:381–396 A description of the recommendations of an expert North American panel consisting of fellows of the Infectious Diseases Society of America on how best to use antimicrobial agents in febrile neutropenic patients.PubMedCrossRefGoogle Scholar
- Immunocompromised Host Society Consensus Panel (1990) The design, analysis and reporting of clinical trials on the empirical antibiotic management of the neutropenic patient. J Infect Dis 161:397–401 The description of the recommendations for carrying out clinical trials on empiric antibiotic management of neutropenic patients based on a consensus meeting of international experts held in 1989.CrossRefGoogle Scholar
- Pater JL, Wier L (1986) Reporting the results of randomized trials of empiric antibiotics in febrile neutropenic patients - a critical survey. J Clin Oncol 4:346–352 A retrospective review of 21 randomized trials on empiric antibiotics in febrile neutropenic patients pointing out the reporting problems in different studies.PubMedGoogle Scholar