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Proposal 1161

Title of the Proposed Research

Novel approaches to the prediction of influenza complications

Lead Researcher

Mark H. Ebell MD, MS.

Affiliation

Department of Epidemiology and Biostatistics
College of Public Health
University of Georgia
Athens, GA 30602

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

18 August 2015

Lay Summary

Influenza is a common condition, affecting millions of Americans every year. While it is usually a self-limited illness, some patients experience complications such as pneumonia or hospitalization. It would be helpful to be able to identify patients at high risk for complications, who could be followed more closely. The goal of our research is to develop one or more practical, validated, accurate tools to predict the likelihood of complications among patients with influenza-like illness and the subset who have proven influenza A or B virus infection.

Aim 1: Use logistic regression to develop and validate a point score that predicts complications requiring an antibiotic or hospitalization in patients with flu or flu-like illness.
Aim 2: Use classification and regression tree analysis to develop and validate a decision tree that predicts complications requiring an antibiotic or hospitalization in patients with flu or flu-like illness.

Study Data Provided

Study ROCHE-WV15670: A double-blind, randomized, placebo-controlled study of oral Ro 64-0796 (GS4104) in the treatment of influenza infection
Study ROCHE-WV15671: A double-blind, randomized, placebo controlled study of GS4104 (Ro 64-0796) in the treatment of influenza infection
Study ROCHE-WV15730: A double blind,randomised, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza infection
Study ROCHE-WV15707: A double-blind, stratified, randomized, placebo controlled study of Ro 64-0796 (GS4104) in the treatment of influenza infection in elderly adults
Study ROCHE-M76001: A randomized, double-blind, placebo-controlled, multicenter study of efficacy based on the time to treatment of influenza infection with the neuraminidase inhibitor Ro 64-0796 (also known as GS4104)
Study ROCHE-WV15812: A double-blind, stratified, randomized, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza in chronically ill adults
Study ROCHE-WV15872: A double-blind, stratified, randomized, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza in chronically ill adults
Study ROCHE-WV15819: A double-blind, randomized, stratified, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza infection in elderly patients
Study ROCHE-WV15876: A double-blind, randomized, stratified, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza infection in elderly patients
Study ROCHE-WV15978: A double-blind, randomized, stratified, placebo controlled study of Ro 64-0796 (also known as GS4104) in the treatment of influenza infection in elderly patients
Study ROCHE-WV16277: A double-blind, randomized, stratified, placebo-controlled study of oseltamivir in the treatment of influenza infection in patients

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.