GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults

Summary

The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

Timeline

Start

2004-09-01

Primary completion

2007-04-01

Completion

2007-04-15

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Low GR270773; p = 0.329; Rate difference 1.1; Chi-squared NCT00089986 ↗

registry analysis (superiority or other test); Placebo vs High GR270773; p = 0.879; Rate Difference -4.4; Chi-squared NCT00089986 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GR270773	Unknown	—	Intravenous

Indications