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OpenTrials
Completed

NCT Number: NCT00190788

Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion

The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.

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Key information

Conditions

Sepsis Cardiovascular Diseases Hypotension Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary 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., Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
  • Continue requirement of Vasopressor support after 96 hour commercial infusion

Exclusion criteria

  • Patients require extensive surgical procedures within next 3 days
  • Patients with platelet count below 30,000/mm3
  • Patients receiving therapeutic heparin of 15,000 units/day and more
  • Patients not expected to survive 24 days
  • Patients contraindicated as to the country specific registration

Treatment and study plan

Drotrecogin Alfa (Activated)

Drug

Placebo

Drug

Primary outcomes

  1. - To assess whether continued administration of Drotrecogin Alfa (Activated)for up to 72 additional hours after 96 hours infusion of commercial DDA results in more rapid resolution of vasopressor-dependent hypotension

Secondary outcomes

  1. Evaluate Reduction of 28-day all cause mortality

  2. Evaluate effects on various organ functions over 14 days

  3. Evaluate effects on the concentration of various biomarkers

  4. Investigate safety profile of an extended infusion of DDA

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96 Hour Infusion With Commercial Drotrecogin Alfa (Activated)

Important dates

Study start
2004
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Oct 12, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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