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Preface

Preface J Antimicrob Chemother 2010; 65 Suppl 4: iv1 doi:10.1093/jac/dkq271 Now and then (and increasingly not often enough) a new antibiotic Although they make a significant contribution to the practice approaches the threshold of clinical use. What should the clinician of evidenced-based medicine, RCTs nonetheless suffer from ask as minimum requirements before adopting the drug for clinical some drawbacks in that they are not powered to uncover rare use? Before reaching the stage of clinical testing, a potential new (and maybe severe) side effects, the included patients are not therapeutic agent will have been characterized in terms of its spec- always representative of the population of patients in whom trum of antibacterial activity (both in vitro and in vivo), its pharma- the drug will be used in clinical practice and they cannot cokinetic and pharmacodynamic profile and potential toxicity. address the question of long-term selection of resistance. However, for the practicing clinician, the most important criterion Other study designs including systematic reviews and meta- relates to its performance in clinical tests. For a new antibiotic to be analyses, as well as large observational studies, are needed for adopted in clinical practice, it should have a clear niche or a clear these purposes. advantage over existing agents, and this should be tested in ran- This Supplement, which provides not only microbiological, domized clinical trials (RCTs). For example, we do not need new pharmacokinetic/pharmacodynamic and safety information antibiotics for skin and soft tissue infections with one major excep- about the new cephalosporin antibiotic ceftaroline fosamil, tion, namely the effective treatment of infections due to should serve the practicing clinician by also presenting the full methicillin-resistant Staphylococcus aureus (MRSA), especially if data from the two clinical trials on skin and skin structure infec- the new drug can be given both intravenously and orally. tions performed to date. The above caveats not withstanding, Ideally, RCTs should include patients who need antibiotic the provision of these clinical trial data together with the com- treatment. Mild skin infections or superficial abscesses that prehensive overview of ceftaroline fosamil should prove a valu- were well drained should not be entered in such studies, as able resource for clinicians involved in the treatment of they drive up the percentage of success and favour equivalence. infections in the era of community-associated MRSA. In addition, the number of included patients should be high enough to prove equivalence. The main outcome should be Alan P. Johnson one that is important to patients, and should be reported for Leonard Leibovici all the patients that were randomized (intention-to-treat group). Outcomes in sub-groups (modified intention-to-treat, or patients with microbiologically documented infections) can be reported, but they should not substitute for the intention- Transparency declarations to-treat analysis. Adverse effects need to be described in detail, with detailed reporting on severe adverse events. None to declare. # The Author 2010. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: [email protected] iv1 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Antimicrobial Chemotherapy Oxford University Press

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Publisher
Oxford University Press
Copyright
The Author 2010. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissionsoxfordjournals.org
Subject
Preface
ISSN
0305-7453
eISSN
1460-2091
DOI
10.1093/jac/dkq271
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Abstract

J Antimicrob Chemother 2010; 65 Suppl 4: iv1 doi:10.1093/jac/dkq271 Now and then (and increasingly not often enough) a new antibiotic Although they make a significant contribution to the practice approaches the threshold of clinical use. What should the clinician of evidenced-based medicine, RCTs nonetheless suffer from ask as minimum requirements before adopting the drug for clinical some drawbacks in that they are not powered to uncover rare use? Before reaching the stage of clinical testing, a potential new (and maybe severe) side effects, the included patients are not therapeutic agent will have been characterized in terms of its spec- always representative of the population of patients in whom trum of antibacterial activity (both in vitro and in vivo), its pharma- the drug will be used in clinical practice and they cannot cokinetic and pharmacodynamic profile and potential toxicity. address the question of long-term selection of resistance. However, for the practicing clinician, the most important criterion Other study designs including systematic reviews and meta- relates to its performance in clinical tests. For a new antibiotic to be analyses, as well as large observational studies, are needed for adopted in clinical practice, it should have a clear niche or a clear these purposes. advantage over existing agents, and this should be tested in ran- This Supplement, which provides not only microbiological, domized clinical trials (RCTs). For example, we do not need new pharmacokinetic/pharmacodynamic and safety information antibiotics for skin and soft tissue infections with one major excep- about the new cephalosporin antibiotic ceftaroline fosamil, tion, namely the effective treatment of infections due to should serve the practicing clinician by also presenting the full methicillin-resistant Staphylococcus aureus (MRSA), especially if data from the two clinical trials on skin and skin structure infec- the new drug can be given both intravenously and orally. tions performed to date. The above caveats not withstanding, Ideally, RCTs should include patients who need antibiotic the provision of these clinical trial data together with the com- treatment. Mild skin infections or superficial abscesses that prehensive overview of ceftaroline fosamil should prove a valu- were well drained should not be entered in such studies, as able resource for clinicians involved in the treatment of they drive up the percentage of success and favour equivalence. infections in the era of community-associated MRSA. In addition, the number of included patients should be high enough to prove equivalence. The main outcome should be Alan P. Johnson one that is important to patients, and should be reported for Leonard Leibovici all the patients that were randomized (intention-to-treat group). Outcomes in sub-groups (modified intention-to-treat, or patients with microbiologically documented infections) can be reported, but they should not substitute for the intention- Transparency declarations to-treat analysis. Adverse effects need to be described in detail, with detailed reporting on severe adverse events. None to declare. # The Author 2010. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: [email protected] iv1

Journal

Journal of Antimicrobial Chemotherapy – Oxford University Press

Published: Nov 1, 2010

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