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市中肺炎に対する無作為化埋め込み型多因子適応プラットフォーム試験

基本情報

NCT ID
NCT02735707
ステータス
募集中
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
20,000
治験依頼者名
UMC Utrecht

概要

REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.

対象疾患

Community-acquired Pneumonia, Influenza, COVID-19

介入

Ceftriaxone(DRUG)
Moxifloxacin or Levofloxacin(DRUG)
Piperacillin-tazobactam(DRUG)
Ceftaroline(DRUG)
Amoxicillin-clavulanate(DRUG)
Standard course macrolide(DRUG)
No Immune Modulator for Influenza(OTHER)
Extended course macrolide(DRUG)
No systemic corticosteroid(OTHER)
Fixed-duration Hydrocortisone(DRUG)
Shock-dependent hydrocortisone(DRUG)
Fixed-duration higher dose Hydrocortisone(DRUG)
No antiviral agent for influenza(OTHER)
Five-days oseltamivir(DRUG)
Ten-days oseltamivir(DRUG)
No antiviral agent for COVID-19(OTHER)
Lopinavir / Ritonavir(DRUG)
Hydroxychloroquine(DRUG)
Hydroxychloroquine + lopinavir/ritonavir(DRUG)
Ivermectin(DRUG)
No immune modulation for COVID-19(OTHER)
Interferon beta-1a(DRUG)
Anakinra(DRUG)
Tocilizumab(DRUG)
Sarilumab(DRUG)
Local standard venous thromboprophylaxis(DRUG)
Therapeutic dose anticoagulation(DRUG)
Conventional low dose thromboprophylaxis(DRUG)
Intermediate dose thromboprophylaxis(DRUG)
Continuation of therapeutic dose anticoagulation(DRUG)
No immunoglobulin(OTHER)
Convalescent plasma(BIOLOGICAL)
Delayed administration of convalescent plasma(BIOLOGICAL)
No vitamin C(OTHER)
Vitamin C(DRUG)
No antiplatelet(OTHER)
Aspirin(DRUG)
P2Y12 inhibitor(DRUG)
No simvastatin(OTHER)
Simvastatin(DRUG)
Eritoran(DRUG)
Apremilast(DRUG)
Clinician-preferred mechanical ventilation strategy(PROCEDURE)
Protocolised mechanical ventilation strategy(PROCEDURE)
No renin-angiotensin system inhibitor(OTHER)
Angiotensin converting enzyme inhibitor(DRUG)
Angiotensin Receptor Blockers(DRUG)
ARB + DMX-200(DRUG)
No cysteamine(OTHER)
Cysteamine(DRUG)
Fixed-duration dexamethasone(DRUG)
Baloxavir Marboxil(DRUG)
Five-days oseltamivir + baloxavir marboxil(DRUG)
Ten-days oseltamivir + baloxavir marboxil(DRUG)
No endothelial modulator(OTHER)
Imatinib(DRUG)
Tocilizumab(DRUG)
Baricitinib(DRUG)
No antiviral agent for COVID-19(OTHER)
Nirmatrelvir/ritonavir(DRUG)
Remdesivir(DRUG)
Nirmatrelvir/ritonavir + remdesivir(DRUG)

依頼者（Sponsor）

Unity Health(OTHER)
St. Marianna University School Of Medicine(OTHER)
Nat Intensive Care Surveillance - Moru(OTHER)
Australian And New Zealand Intensive Care Research Centre(OTHER)
Umc Utrecht(OTHER)
Medical Research Institute Of New Zealand(OTHER)
University Of Pittsburgh Medical Center(OTHER)
Berry Consultants(OTHER)
Intensive Care National Audit & Research Centre(OTHER)
Global Coalition For Adaptive Research(OTHER)
National University Hospital, Singapore(OTHER)

実施施設 (12)

地方独立行政法人東京都立病院機構　東京都立墨東病院

Tokyo, Japan(RECRUITING)

和歌山県立医科大学附属病院

Wakayama, Japan(RECRUITING)

東京ベイ・浦安市川医療センター

Tokyo, Japan(RECRUITING)

St Marianna University School of Medicine

Kawasaki, Kanagawa, Japan(RECRUITING)

医療法人社団保健会　東京湾岸リハビリテーション病院

Tokyo, Japan(RECRUITING)

公立大学法人横浜市立大学附属病院

Yokohama, Kanagawa, Japan(RECRUITING)

Wakayama Medical University

Wakayama, Japan(RECRUITING)

聖マリアンナ医科大学横浜市西部病院

Yokohama, Kanagawa, Japan(RECRUITING)

大阪市立総合医療センター

Osaka, Japan(RECRUITING)

社会福祉法人恩賜財団済生会熊本病院

Minami, Kumamoto, Japan(RECRUITING)

日本大学医学部徳沢診療所

Kawasaki, Kanagawa, Japan(RECRUITING)

医療法人社団明芳会　板橋中央総合病院

Tokyo, Japan(RECRUITING)