Outcome assessment in cellulitis clinical trials: is telephone follow up sufficient?

Abstract

The US Food and Drug Administration has scrutinized clinical trial methodology in cellulitis, partly because the definition and timing of cure are debatable. We analysed the validity of telephone self-report as a proxy for in-person follow up in a cellulitis treatment trial comparing cephalexin alone with cephalexin-plus-trimethoprim/sulfamethoxazole. Our results demonstrate poor agreement between these two methods of outcome determination and have implications for future cellulitis clinical trial design and clinical management.

• Authors: V E Nambudiri, R C Dwyer, C A Camargo Jr, T S Kupper, D J Pallin
• Journal: Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases (Clin Microbiol Infect) Vol. 21 Issue 7 Pg. 676.e5-7 (Jul 2015) ISSN: 1469-0691 [Electronic] England
• PMID: 25882364 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Anti-Bacterial Agents
• Trimethoprim, Sulfamethoxazole Drug Combination
• Cephalexin

Topics

• Adolescent
• Adult
• Aged
• Anti-Bacterial Agents (administration & dosage)
• Cellulitis (drug therapy)
• Cephalexin (administration & dosage)
• Child
• Child, Preschool
• Clinical Trials as Topic
• Humans
• Interviews as Topic
• Middle Aged
• Treatment Outcome
• Trimethoprim, Sulfamethoxazole Drug Combination (administration & dosage)
• United States
• Young Adult