A Phase 4 interventional study of drotrecogin alfa (activated) in Severe Sepsis, sponsored by Eli Lilly and Company. Completed at 18 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-06.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
This trial is to obtain safety data in adult patients with severe sepsis and two sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).
To collect safety data while providing drotrecogin alfa (activated) for the treatment of patients with severe sepsis with multiple organ dysfunctions. Patient access to drotrecogin alfa (activated) will be provided under this protocol prior to and during its review by the Authorities of Belgium and Luxemburg for commercial release.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 130 is above the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:
Exclusion Criteria:
Patients will be excluded from entry in this study for any of the following reasons:
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
Drug: drotrecogin alfa (activated)
Also known as: LY203638, Xigris
Safety Data
Time frame: 9 Months
All cause mortality data.
Time frame: 9 Months
To determine the final disposition of sepsis patients treated with drotrecogin alfa (activated)(that is, patient location at discharge from study hospital or 90 days).
Time frame: 9 Months
This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Drotrecogin alfa activated