SepsisPhase 3NCT00049764

Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

A Phase 3 study testing Drotrecogin alfa (activated) in people with Sepsis, run by Eli Lilly and Company at 49 sites in 11 countries.

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

The purposes of this study are to determine: 1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated). 2. Read more about this study

Who is it for?: Ages Up to 17 years
Conditions the study is for: Sepsis
What is being tested?: Drotrecogin alfa (activated)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 474 participants
Where: 49 sitesin 11 countries
Study dates: Nov 2002to Apr 2005
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 Up to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Suspected or proven acute infection.
Abnormally high or low core body temperature
Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis.
Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis.

Who cannot join

Patients at increased risk of bleeding.
Patients at high risk for an intracranial bleed.
Patients who have undergone a bone marrow transplant.
Patients with end-stage renal disease.
Patients whose family or primary care physician is unwilling to allow transfusion of blood products.

Trial locations and contacts

49 sites in 11 countries.

Country

City, postcode or hospital

49 sites in 11 countries

United States23 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.
Albany, New York
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Ann Arbor, Michigan
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Birmingham, Alabama
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Boise, Idaho
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Charleston, South Carolina
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Chicago, Illinois
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Falls Church, Virginia
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Hershey, Pennsylvania
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Indianapolis, Indiana
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Kansas City, Missouri
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Madera, California
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Nashville, Tennessee
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New Hyde Park, New York
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New York, New York
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Oak Lawn, Illinois
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Oklahoma City, Oklahoma
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Park Ridge, Illinois
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Pittsburgh, Pennsylvania
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San Antonio, Texas
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San Diego, California
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Tucson, Arizona
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Tuscon, Arizona
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Washington D.C., District of Columbia

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France7 sites

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Amiens
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Bordeaux
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Le Kremlin-Bicêtre
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Lyon
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Marseille
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Nantes
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Toulouse

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United Kingdom7 sites

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Birmingham
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Bloomsbury, London
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London
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Manchester
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Paddington, London
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Southhampton, Hants
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Southhampton

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Germany3 sites

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Erlangen
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Magdeburg
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Würzburg

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Australia2 sites

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Hobart, Tasmania
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Westmead, New South Wales

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Slovakia2 sites

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Banska, Bystrica
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Bratislava

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Chile1 site

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Santiago

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Italy1 site

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Milan

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Mexico1 site

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Mexico City, Benito Juarez

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Poland1 site

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Lublin

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Switzerland1 site

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Zurich

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About this study

The purposes of this study are to determine:

Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

Read the detailed description

The primary objective was to demonstrate that drotrecogin alfa (activated) compared with placebo reduced severe-sepsis-induced organ dysfunction as assessed by time to complete resolution of a composite of cardiovascular, respiratory, and renal organ failure in pediatric patients with severe sepsis.

Secondary objectives included: (1) to assess whether treatment with drotrecogin alfa (activated) reduced 28-day all-cause mortality in pediatric patients with severe sepsis compared with placebo patients, (2) to evaluate the effects of drotrecogin alfa (activated) on individual organ dysfunction (cardiovascular, respiratory, renal, hepatic, hematologic, neurologic, and cutaneous), (3) to demonstrate that drotrecogin alfa (activated) improved patient outcome as assessed by the Pediatric Overall Performance Category (POPC) scale, (4) to demonstrate that drotrecogin alfa (activated) reduced major amputations (at or above the wrist, at or above the ankle, face, and genitals) in pediatric patients with Neisseria meningitidis (proven or suspected) and/or purpura fulminans, (5) to demonstrate that drotrecogin alfa (activated) had antithrombotic and anti-inflammatory properties. The safety objective was to evaluate whether drotrecogin alfa (activated) had an acceptable safety profile when administered to pediatric patients with severe sepsis.

Conditions: Sepsis
Being tested: Drotrecogin alfa (activated), Placebo
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
PlaceboDrug

Study groups in NCT00049764
Study group	Role	What they receive
1	Experimental	24 microgram/kg/hr for 96 hours (+ or - 1 hour) Receives: Drug: Drotrecogin alfa (activated)
2	Placebo comparator	0.9% sodium chloride Receives: Drug: Placebo

What is being measured

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

That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Measured: 3 Years

Secondary outcomes (4)

All cause mortality data
Measured: 3 Years
The effects of drotrecogin alfa (activated) on individual organ dysfunction
Measured: 3 Years
Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
Measured: 3 Years
Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Measured: 3 Years

Timeline

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

Nov 2002Apr 2005

First posted14 Nov 2002 (estimated)
Study startNov 2002
Study completionApr 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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
Who is masked: Participant, Investigator
Enrolment: 474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00049764
Sponsor's protocol ID: 6716
Other IDs: F1K-MC-EVBP
Status last verified: Nov 2007
First submitted: 13 Nov 2002
Last updated: 20 Nov 2007
Results posted: No
Data monitoring committee: Yes

Publications

Farris RW, Weiss NS, Zimmerman JJ. Functional outcomes in pediatric severe sepsis: further analysis of the researching severe sepsis and organ dysfunction in children: a global perspective trial. Pediatr Crit Care Med. 2013 Nov;14(9):835-42. doi: 10.1097/PCC.0b013e3182a551c8.
PubMed 24108117
Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-843. doi: 10.1016/S0140-6736(07)60411-5.
PubMed 17350452

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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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
ClinicalTrials.gov ID: NCT00049764
Acronym / sponsor ID: 6716
Conditions: Sepsis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 474 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2002
Study completion: Apr 2005 (actual)
First posted: 14 Nov 2002 (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 purposes of this study are to determine:

Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Drotrecogin alfa (activated)24 microgram/kg/hr for 96 hours (+ or - 1 hour)
2	Placebo comparator	Drug: Placebo0.9% sodium chloride

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Suspected or proven acute infection.
Abnormally high or low core body temperature
Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis.
Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis.

Key exclusion criteria (5 listed)

Patients at increased risk of bleeding.
Patients at high risk for an intracranial bleed.
Patients who have undergone a bone marrow transplant.
Patients with end-stage renal disease.
Patients whose family or primary care physician is unwilling to allow transfusion of blood products.

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
Placebo	Drug	2

Primary outcome

That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Time frame: 3 Years

4 secondary outcomes

All cause mortality data
Time frame: 3 Years
The effects of drotrecogin alfa (activated) on individual organ dysfunction
Time frame: 3 Years
Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
Time frame: 3 Years
Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Time frame: 3 Years

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 20 Nov 2007.
Derived from this study: PubMed 24108117Farris RW, Weiss NS, Zimmerman JJ. Functional outcomes in pediatric severe sepsis: further analysis of the researching severe sepsis and organ dysfunction in children: a global perspective trial. Pediatr Crit Care Med. 2013 Nov;14(9):835-42. doi: 10.1097/PCC.0b013e3182a551c8.
Derived from this study: PubMed 17350452Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-843. doi: 10.1016/S0140-6736(07)60411-5.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

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

49 sites in 11 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, run by Eli Lilly and Company at 49 sites in 11 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 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 20 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, France, United Kingdom, Germany, Australia and 6 more countries. 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. Some participants in this study may receive a placebo. 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?

That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction (time frame: 3 Years). 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 NCT00049764, which also lists 2 linked publications.

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 20 Nov 2007.