SepsisPhase 3NCT00190788
Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion
A Phase 3 study testing Drotrecogin Alfa (Activated) in people with Sepsis and Hypotension, run by Eli Lilly and Company at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Hypotension
- What is being tested?
- Drotrecogin Alfa (Activated)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2004to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
- Continue requirement of Vasopressor support after 96 hour commercial infusion
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
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.
Loma Linda, California, 92350
France1 site
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, 75679
About this study
Official 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)
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.
- Conditions
- Sepsis, Hypotension
- Being tested
- Drotrecogin Alfa (Activated), placebo
- Medical subject headings
- Sepsis, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drotrecogin Alfa (Activated)Drug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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 (4)
Evaluate Reduction of 28-day all cause mortality
Evaluate effects on various organ functions over 14 days
Evaluate effects on the concentration of various biomarkers
Investigate safety profile of an extended infusion of DDA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2004
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190788
- Sponsor's protocol ID
- 6001
- Other IDs
- F1K-MC-EVBQ
- Status last verified
- Oct 2007
- First submitted
- 12 Sep 2005
- Last updated
- 12 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00190788
- Acronym / sponsor ID
- 6001
- Conditions
- Sepsis, Hypotension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- May 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
- Continue requirement of Vasopressor support after 96 hour commercial infusion
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drotrecogin Alfa (Activated) | Drug | – |
| placebo | Drug | – |
Primary outcome
- 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
4 secondary outcomes
Evaluate Reduction of 28-day all cause mortality
Evaluate effects on various organ functions over 14 days
Evaluate effects on the concentration of various biomarkers
Investigate safety profile of an extended infusion of DDA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drotrecogin Alfa (Activated) in people with Sepsis and Hypotension, run by Eli Lilly and Company at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2007.