An Open Label Study of Severe Sepsis in Adults

NCT00568893 | Completed Phase 4

• 2 other identifiers: 7159F1K-BX-S001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 18

Brief Summary

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).

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• Safety Data

  9 Months

Secondary Outcomes (2)

• All cause mortality data.

  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).

  9 Months

Study Arms (1)

1

EXPERIMENTAL

24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Drug: drotrecogin alfa (activated)

Interventions

drotrecogin alfa (activated) DRUG

Also known as: LY203638, Xigris

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:
• Must be 18 years.
• Suspected or proven infection
• Have or have had two or more sepsis-induced organ failures sepsis

You may not qualify if:

• Patients will be excluded from entry in this study for any of the following reasons:
• Documented first organ dysfunction greater than 48-hours prior to start of study drug.
• Patients greater than 135 kg in weight.
• Patients with a platelet count less than 30,000/mm3
• Active internal bleeding or at increased risk for bleeding

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (18)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Antwerp, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arlon, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bonheiden, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bruges, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Brussels, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ghent, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Haine-St. Paul, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hasselt, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Huy, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

La Louvière, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Leuven, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Liège, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mons, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Montigny-le-Tilleul, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ottignies, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Roeselare, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Verviers, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Wilrijk, Belgium

Location

Related Publications (1)

• Hodder RV, Hall R, Russell JA, Fisher HN, Lee B. Early drotrecogin alpha (activated) administration in severe sepsis is associated with lower mortality: a retrospective analysis of the Canadian ENHANCE cohort. Crit Care. 2009;13(3):R78. doi: 10.1186/cc7893. Epub 2009 May 20.

  PMID: 19457240 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Sepsis

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: January 1, 2003
• Study Completion: October 1, 2003
• Last Updated: December 6, 2007

Record last verified: 2007-12

Locations

BE (18)