Evaluation of new anti-infective drugs for the treatment of viral encephalitis. Infectious Diseases Society of America and the Food and Drug Administration.

Academic Article

Abstract

  • Viral encephalitis may develop subsequent to viremia, via neuronal spread, or by arthropod vector. Diagnosis often requires invasive studies such as lumbar puncture and brain biopsy. This guideline addresses herpes simplex, rabies, and arbovirus infections of the central nervous system. Clinical trials should be designed according to the availability of approved therapeutic agents. Study designs with an active control (herpesvirus), a placebo control (arbovirus), or no control (rabies virus) are recommended. Outcome should be assessed 4-6 weeks, 4-6 months, and 11-13 months after the completion of therapy. For newborns with encephalitis, outcome should be assessed yearly through the age of 5 years. Assessment of clinical outcome is paramount.
  • Published In

    Keywords

  • Anti-Infective Agents, Clinical Protocols, Clinical Trials as Topic, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Encephalitis, Humans, Research Design, Virus Diseases
  • Digital Object Identifier (doi)

    Author List

  • Whitley RJ; Lentnek A; McCracken GH; Sande MA; Scheld WM
  • Start Page

  • S195
  • End Page

  • S199
  • Volume

  • 15 Suppl 1