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Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®

perjantai 10. helmikuuta 2017 päivittänyt: AbbVie
This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of serious lower respiratory tract infection caused by RSV in participants 24 months of age and under, who have an immunocompromised medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other types of immunodeficiency; HIV infection; recovering from organ or bone marrow transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants) or who have Down syndrome.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Yksityiskohtainen kuvaus

Palivizumab was prescribed according to the local label and independently of the decision to enroll participants in the study. Palivizumab was administered monthly throughout the Respiratory Syncytial Virus (RSV) infection seasons via intramuscular injection at a dose of 15 mg/kg of body weight. Survey forms were collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed participants were assessed to evaluate the safety and effectiveness of palivizumab.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

312

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 2 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

Single-arm, Multi-center, Prospective Cohort

Kuvaus

Inclusion Criteria:

  1. Availability of a parent or legal guardian who was capable and willing to give written informed consent for his/her newborn, infant or young child to participate in the study
  2. Participants receiving palivizumab for prevention of serious lower respiratory tract disease caused by RSV infection

  3. Newborns, infants, or young children 24 months of age and under who have an immunocompromised medical condition:

    • combined immunodeficiency, (severe combined immunodeficiency, X-linked hyper-immunoglobulin M (IgM) syndrome, etc.), antibody deficiency (X-linked agammaglobulinemia,common variable immunodeficiency, non-X-linked hyper-IgM syndrome,etc.) or other immunodeficiency (Wiskott-Aldrich syndrome, etc.)
    • acquired T cell dysfunction ( such as human immunodeficiency virus (HIV) infection etc.)
    • history of past organ transplantation
    • history of past bone marrow transplantation
    • receiving immunosuppressive chemotherapy
    • receiving systemic high-dose corticosteroid therapy (prednisone equivalents ≥ 0.5 mg/kg/every other day, other than inhaler or topical use), or
    • receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc.)
    • receiving biologics (including cytokine inhibitors)
    • Others (nephrotic syndrome, chronic peritoneal dialysis, hemodialysis)
  4. Newborns, infants, or young children age of 24 months and under who have Down syndrome without a current hemodynamically significant Congenital Heart Disease. The participant must have had an experience with persistent respiratory symptoms or regular outpatient treatment due to respiratory tract infection prior to current RSV season.

Exclusion criteria:

  1. Participants included in the Contraindications section of the package insert
  2. Participants with known hypersensitivity to the ingredients of palivizumab
  3. Participants with a known positive RSV infection before hospitalization

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Immunocompromised children
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Adverse Events
Aikaikkuna: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Participants With Serious Adverse Events
Aikaikkuna: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Participants With Adverse Drug Reactions
Aikaikkuna: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: "Related", "Causality cannot be ruled out", or "Not assessable" as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: "Death", "Life-threatening condition", "Hospitalization or prolonged hospitalization", "Persistent or significant disability", or "Other medically important condition". Information about AEs and ADRs was documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
Aikaikkuna: From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks
The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).
From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks
Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection
Aikaikkuna: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection
Aikaikkuna: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Number of Hospitalized Participants Requiring Respiratory Support
Aikaikkuna: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
Mean Duration of Respiratory Support
Aikaikkuna: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).
From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

AbbVie

Tutkijat

  • Opintojohtaja: Osamu Mikami, MD, PhD, AbbVie GK.

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

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

Sunnuntai 1. joulukuuta 2013

Ensisijainen valmistuminen (Todellinen)

Tiistai 1. joulukuuta 2015

Opintojen valmistuminen (Todellinen)

Tiistai 1. joulukuuta 2015

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 11. joulukuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 16. joulukuuta 2013

Ensimmäinen Lähetetty (Arvio)

Perjantai 20. joulukuuta 2013

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 20. maaliskuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 10. helmikuuta 2017

Viimeksi vahvistettu

Keskiviikko 1. helmikuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • P14-296

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

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 .

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