Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
15. november 2007 oppdatert av: Eli Lilly and Company
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
474
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New South Wales
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Westmead, New South Wales, Australia
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Tasmania
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Hobart, Tasmania, Australia
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Santiago de Chile, Chile
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Alabama
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Birmingham, Alabama, Forente stater
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Arizona
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Tucson, Arizona, Forente stater
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Tuscon, Arizona, Forente stater
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California
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Madera, California, Forente stater
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San Diego, California, Forente stater
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District of Columbia
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Washington DC, District of Columbia, Forente stater
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Idaho
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Boise, Idaho, Forente stater
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Illinois
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Chicago, Illinois, Forente stater
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Oak Lawn, Illinois, Forente stater
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Park Ridge, Illinois, Forente stater
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Indiana
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Indianapolis, Indiana, Forente stater
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Michigan
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Ann Arbor, Michigan, Forente stater
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Missouri
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Kansas City, Missouri, Forente stater
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New York
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Albany, New York, Forente stater
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New Hyde Park, New York, Forente stater
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New York, New York, Forente stater
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater
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Pennsylvania
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Hershey, Pennsylvania, Forente stater
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Pittsburgh, Pennsylvania, Forente stater
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South Carolina
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Charleston, South Carolina, Forente stater
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Tennessee
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Nashville, Tennessee, Forente stater
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Texas
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San Antonio, Texas, Forente stater
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Virginia
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Falls Church, Virginia, Forente stater
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Amiens, Frankrike
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Amiens Cedex, Frankrike
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Bordeaux, Frankrike
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Le Kremlin-Bicetre, Frankrike
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Lyon, Frankrike
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Lyon Cedex 03, Frankrike
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Marseille, Frankrike
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Nantes, Frankrike
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Toulouse, Frankrike
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Milano, Italia
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Benito Juarez
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Mexico City, Benito Juarez, Mexico
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Lublin, Polen
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Bratislava, Slovakia
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Bystrica
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Banska, Bystrica, Slovakia
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Birmingham, Storbritannia
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London, Storbritannia
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Manchester, Storbritannia
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Southhampton, Storbritannia
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Hants
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Southhampton, Hants, Storbritannia
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London
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Bloomsbury, London, Storbritannia
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Paddington, London, Storbritannia
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Zurich, Sveits
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Erlangen, Tyskland
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Magdeburg, Tyskland
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Wurzburg, Tyskland
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
24 mikrogram/kg/time i 96 timer (+ eller - 1 time)
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Andre navn:
|
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Placebo komparator: 2
0,9% natriumklorid
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Tidsramme: 3 Years
|
3 Years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
All cause mortality data
Tidsramme: 3 Years
|
3 Years
|
|
The effects of drotrecogin alfa (activated) on individual organ dysfunction
Tidsramme: 3 Years
|
3 Years
|
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Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
Tidsramme: 3 Years
|
3 Years
|
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Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Tidsramme: 3 Years
|
3 Years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2002
Studiet fullført (Faktiske)
1. april 2005
Datoer for studieregistrering
Først innsendt
13. november 2002
Først innsendt som oppfylte QC-kriteriene
13. november 2002
Først lagt ut (Anslag)
14. november 2002
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. november 2007
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. november 2007
Sist bekreftet
1. november 2007
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 6716
- F1K-MC-EVBP
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .