Severe SepsisPhase 4NCT00568893

An Open Label Study of Severe Sepsis in Adults

A Phase 4 study testing drotrecogin alfa (activated) in people with Severe Sepsis, run by Eli Lilly and Company at 18 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Sepsis
What is being tested?: drotrecogin alfa (activated)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 18 sitesBelgium
Study dates: Jan 2003to Oct 2003
Phase: Phase 4
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

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

Who cannot join

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

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Belgium18 sites

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Other trials in Belgium

About this study

Official title: An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol

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).

Read the detailed description

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.

Conditions: Severe Sepsis
Being tested: drotrecogin alfa (activated)
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

drotrecogin alfa (activated)Drug
Also called LY203638, Xigris

Study groups in NCT00568893
Study group	Role	What they receive
1	Experimental	24 microgram/kg/hr for 96 hours (+ or - 1 hour) Receives: Drug: drotrecogin alfa (activated)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Data
Measured: 9 Months

Secondary outcomes (2)

All cause mortality data.
Measured: 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).
Measured: 9 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Oct 2003

First posted6 Dec 2007 (estimated)
Study startJan 2003
Study completionOct 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Severe 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00568893
Sponsor's protocol ID: 7159
Other IDs: F1K-BX-S001
Status last verified: Dec 2007
First submitted: 5 Dec 2007
Last updated: 6 Dec 2007
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 19457240

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol
ClinicalTrials.gov ID: NCT00568893
Acronym / sponsor ID: 7159
Conditions: Severe Sepsis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2003
Study completion: Oct 2003 (actual)
First posted: 6 Dec 2007 (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.

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).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: drotrecogin alfa (activated)24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:

Key exclusion criteria (5 listed)

Patients will be excluded from entry in this study for any of the following reasons:

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)Also: LY203638, Xigris	Drug	1

Primary outcome

Safety Data
Time frame: 9 Months

2 secondary outcomes

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

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 6 Dec 2007.
Derived from this study: PubMed 19457240Hodder 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.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Severe Sepsis

RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
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Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
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Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Recruiting
Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Septic Shock, Methylene Blue

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing drotrecogin alfa (activated) in people with Severe Sepsis, run by Eli Lilly and Company at 18 sites in Belgium.

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 4 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 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Safety Data (time frame: 9 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00568893, which also lists 1 linked publication.

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 6 Dec 2007.