Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
torstai 15. marraskuuta 2007 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
474
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
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Opiskelupaikat
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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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Milano, Italia
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Benito Juarez
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Mexico City, Benito Juarez, Meksiko
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Lublin, Puola
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Amiens, Ranska
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Amiens Cedex, Ranska
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Bordeaux, Ranska
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Le Kremlin-Bicetre, Ranska
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Lyon, Ranska
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Lyon Cedex 03, Ranska
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Marseille, Ranska
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Nantes, Ranska
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Toulouse, Ranska
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Erlangen, Saksa
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Magdeburg, Saksa
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Wurzburg, Saksa
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Bratislava, Slovakia
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Bystrica
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Banska, Bystrica, Slovakia
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Zurich, Sveitsi
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Birmingham, Yhdistynyt kuningaskunta
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London, Yhdistynyt kuningaskunta
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Manchester, Yhdistynyt kuningaskunta
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Southhampton, Yhdistynyt kuningaskunta
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Hants
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Southhampton, Hants, Yhdistynyt kuningaskunta
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London
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Bloomsbury, London, Yhdistynyt kuningaskunta
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Paddington, London, Yhdistynyt kuningaskunta
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Alabama
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Birmingham, Alabama, Yhdysvallat
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Arizona
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Tucson, Arizona, Yhdysvallat
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Tuscon, Arizona, Yhdysvallat
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California
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Madera, California, Yhdysvallat
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San Diego, California, Yhdysvallat
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District of Columbia
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Washington DC, District of Columbia, Yhdysvallat
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Idaho
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Boise, Idaho, Yhdysvallat
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Illinois
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Chicago, Illinois, Yhdysvallat
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Oak Lawn, Illinois, Yhdysvallat
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Park Ridge, Illinois, Yhdysvallat
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Indiana
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Indianapolis, Indiana, Yhdysvallat
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Michigan
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Ann Arbor, Michigan, Yhdysvallat
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Missouri
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Kansas City, Missouri, Yhdysvallat
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New York
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Albany, New York, Yhdysvallat
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New Hyde Park, New York, Yhdysvallat
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New York, New York, Yhdysvallat
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat
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Pennsylvania
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Hershey, Pennsylvania, Yhdysvallat
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Pittsburgh, Pennsylvania, Yhdysvallat
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South Carolina
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Charleston, South Carolina, Yhdysvallat
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Tennessee
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Nashville, Tennessee, Yhdysvallat
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Texas
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San Antonio, Texas, Yhdysvallat
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Virginia
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Falls Church, Virginia, Yhdysvallat
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
Ei vanhempi kuin 17 vuotta (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 1
24 mikrogrammaa/kg/tunti 96 tunnin ajan (+ tai - 1 tunti)
|
Muut nimet:
|
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Placebo Comparator: 2
0,9 % natriumkloridia
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Aikaikkuna: 3 Years
|
3 Years
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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All cause mortality data
Aikaikkuna: 3 Years
|
3 Years
|
|
The effects of drotrecogin alfa (activated) on individual organ dysfunction
Aikaikkuna: 3 Years
|
3 Years
|
|
Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
Aikaikkuna: 3 Years
|
3 Years
|
|
Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Aikaikkuna: 3 Years
|
3 Years
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. marraskuuta 2002
Opintojen valmistuminen (Todellinen)
Perjantai 1. huhtikuuta 2005
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 13. marraskuuta 2002
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 13. marraskuuta 2002
Ensimmäinen Lähetetty (Arvio)
Torstai 14. marraskuuta 2002
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Tiistai 20. marraskuuta 2007
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 15. marraskuuta 2007
Viimeksi vahvistettu
Torstai 1. marraskuuta 2007
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 6716
- F1K-MC-EVBP
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .