- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00049764
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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New South Wales
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Westmead, New South Wales, Australien
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Tasmania
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Hobart, Tasmania, Australien
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Santiago de Chile, Chile
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Birmingham, Det Forenede Kongerige
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London, Det Forenede Kongerige
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Manchester, Det Forenede Kongerige
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Southhampton, Det Forenede Kongerige
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Hants
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Southhampton, Hants, Det Forenede Kongerige
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London
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Bloomsbury, London, Det Forenede Kongerige
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Paddington, London, Det Forenede Kongerige
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Alabama
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Birmingham, Alabama, Forenede Stater
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Arizona
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Tucson, Arizona, Forenede Stater
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Tuscon, Arizona, Forenede Stater
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California
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Madera, California, Forenede Stater
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San Diego, California, Forenede Stater
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District of Columbia
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Washington DC, District of Columbia, Forenede Stater
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Idaho
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Boise, Idaho, Forenede Stater
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Illinois
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Chicago, Illinois, Forenede Stater
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Oak Lawn, Illinois, Forenede Stater
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Park Ridge, Illinois, Forenede Stater
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Indiana
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Indianapolis, Indiana, Forenede Stater
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Michigan
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Ann Arbor, Michigan, Forenede Stater
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Missouri
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Kansas City, Missouri, Forenede Stater
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New York
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Albany, New York, Forenede Stater
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New Hyde Park, New York, Forenede Stater
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New York, New York, Forenede Stater
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater
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Pittsburgh, Pennsylvania, Forenede Stater
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South Carolina
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Charleston, South Carolina, Forenede Stater
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Tennessee
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Nashville, Tennessee, Forenede Stater
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Texas
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San Antonio, Texas, Forenede Stater
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Virginia
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Falls Church, Virginia, Forenede Stater
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Amiens, Frankrig
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Amiens Cedex, Frankrig
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Bordeaux, Frankrig
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Le Kremlin-Bicetre, Frankrig
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Lyon, Frankrig
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Lyon Cedex 03, Frankrig
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Marseille, Frankrig
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Nantes, Frankrig
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Toulouse, Frankrig
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Milano, Italien
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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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Zurich, Schweiz
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Bratislava, Slovakiet
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Bystrica
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Banska, Bystrica, Slovakiet
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Erlangen, Tyskland
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Magdeburg, Tyskland
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Wurzburg, Tyskland
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
24 mikrogram/kg/time i 96 timer (+ eller - 1 time)
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Andre navne:
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Placebo komparator: 2
0,9% natriumchlorid
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Tidsramme: 3 Years
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3 Years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
All cause mortality data
Tidsramme: 3 Years
|
3 Years
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The effects of drotrecogin alfa (activated) on individual organ dysfunction
Tidsramme: 3 Years
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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
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3 Years
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Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Tidsramme: 3 Years
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3 Years
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6716
- F1K-MC-EVBP
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Kliniske forsøg med Sepsis
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University of Kansas Medical CenterUniversity of KansasRekrutteringSepsis | Septisk chok | Sepsis syndrom | Sepsis, svær | Sepsis bakteriel | Sepsis BakteriæmiForenede Stater
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Jip GroenInBiomeRekrutteringMikrobiel kolonisering | Neonatal infektion | Neonatal sepsis, tidligt opstået | Mikrobiel sygdom | Klinisk sepsis | Kultur Negativ Neonatal Sepsis | Neonatal sepsis, sent opstået | Kultur Positiv Neonatal SepsisHolland
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Karolinska InstitutetÖrebro University, SwedenAfsluttetSepsis | Sepsis syndrom | Sepsis, sværSverige
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The University of QueenslandRoyal Brisbane and Women's HospitalUkendt
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Ohio State UniversityAfsluttetSepsis, Svær Sepsis og Septisk ShockForenede Stater
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Indonesia UniversityAfsluttetAlvorlig sepsis med septisk stød | Alvorlig sepsis uden septisk stødIndonesien
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Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRekrutteringAlvorlig sepsis | Alvorlig sepsis uden septisk stødForenede Stater
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Sepsis syndromDet Forenede Kongerige
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Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian... og andre samarbejdspartnereAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Infektion | Sepsis syndromForenede Stater
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Inverness Medical InnovationsAfsluttetSepsis | Systemisk inflammatorisk responssyndrom | Alvorlig sepsis | Sepsis syndromForenede Stater
Kliniske forsøg med Placebo
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SamA Pharmaceutical Co., LtdUkendtAkut bronkitis | Akut øvre luftvejsinfektionKorea, Republikken
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National Institute on Drug Abuse (NIDA)AfsluttetBrug af cannabisForenede Stater
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAfsluttetMandlige forsøgspersoner med type II-diabetes (T2DM)Tyskland
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Heptares Therapeutics LimitedAfsluttetFarmakokinetik | SikkerhedsproblemerDet Forenede Kongerige
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Regado Biosciences, Inc.AfsluttetSund frivilligForenede Stater
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Texas A&M UniversityNutraboltAfsluttetGlucose and Insulin Response
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Longeveron Inc.AfsluttetHypoplastisk venstre hjerte syndromForenede Stater
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ItalfarmacoAfsluttetBeckers muskeldystrofiHolland, Italien
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West Penn Allegheny Health SystemAfsluttetAstma | Allergisk rhinitisForenede Stater