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Center for Global Research Data

Identifying Patients in the PROWESS SHOCK Clinical Trial Among Whom Drotrecogin Alfa (DrottAA) Reduced Mortality

Lead Investigator: Gus Slotman, Inspira Health Network
Title of Proposal Research: Identifying Patients in the PROWESS SHOCK Clinical Trial Among Whom Drotrecogin Alfa (DrottAA) Reduced Mortality
Vivli Data Request: 6710
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

For nearly 40 years, more than 100 randomized clinical trials (RCT), from the original Solu-Medrol RCT through the recent SCARLET RCT, have tested novel interventions targeting the host response to infection in sepsis, organ failure and septic shock on thousands of patients. (1, 2, 3) All of those molecules and regimens were grounded firmly in basic science, both in-vitro and in-vivo. After 40 years of sepsis clinical trials, worldwide sepsis still claims 11 million lives each year. Many new drugs targeting the detrimental effects of sepsis performed well in the laboratory but none reduced septic mortality in clinical trials. Hypothesis: Non-specific clinical sepsis definitions entry criteria enroll so many patients whose bodies cannot benefit from the study drug that the true treatment effects of effective drugs are masked. The present study proposes to determine whether or not it is possible to predict from pre-randomization RCT data which septic patients are able to benefit from Drotrecogin Alfa (DrotAA), a drug from Eli Lilly & Co. If this investigation identifies such patients within the PROWESS SHOCK RCT, then it may be possible to identify drug-responsive patients in other sepsis RCT’s, possibly facilitating new life-saving treatments for sepsis.

Requested Studies:

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock
Sponsor: Eli Lilly and Company
Study ID: NCT00604214
Sponsor ID: 11940