Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
2017년 2월 10일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
관찰
등록 (실제)
312
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
2년 이하 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Single-arm, Multi-center, Prospective Cohort
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Adverse Events
기간: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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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
기간: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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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
기간: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Lower Respiratory Tract Infection (LRI) Score During the Study
기간: From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks
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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
기간: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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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
기간: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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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
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Number of Hospitalized Participants Requiring Respiratory Support
기간: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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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
기간: From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Osamu Mikami, MD, PhD, AbbVie GK.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 12월 1일
기본 완료 (실제)
2015년 12월 1일
연구 완료 (실제)
2015년 12월 1일
연구 등록 날짜
최초 제출
2013년 12월 11일
QC 기준을 충족하는 최초 제출
2013년 12월 16일
처음 게시됨 (추정)
2013년 12월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 2월 10일
마지막으로 확인됨
2017년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P14-296
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .