Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
10 febbraio 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
312
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 2 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Single-arm, Multi-center, Prospective Cohort
Descrizione
Inclusion Criteria:
- 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
- Participants receiving palivizumab for prevention of serious lower respiratory tract disease caused by RSV infection
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)
- 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:
- Participants included in the Contraindications section of the package insert
- Participants with known hypersensitivity to the ingredients of palivizumab
- Participants with a known positive RSV infection before hospitalization
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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Immunocompromised children
Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Adverse Events
Lasso di tempo: 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).
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From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
|
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Number of Participants With Serious Adverse Events
Lasso di tempo: 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).
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From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
|
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Number of Participants With Adverse Drug Reactions
Lasso di tempo: 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).
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From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Lower Respiratory Tract Infection (LRI) Score During the Study
Lasso di tempo: 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).
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From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks
|
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Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection
Lasso di tempo: 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).
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From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
|
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Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection
Lasso di tempo: 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).
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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
Lasso di tempo: 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).
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From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
|
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Mean Duration of Respiratory Support
Lasso di tempo: 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).
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From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Osamu Mikami, MD, PhD, AbbVie GK.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2013
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
11 dicembre 2013
Primo inviato che soddisfa i criteri di controllo qualità
16 dicembre 2013
Primo Inserito (Stima)
20 dicembre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 marzo 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 febbraio 2017
Ultimo verificato
1 febbraio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P14-296
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .