A Rapid Test for Acute Respiratory Illness (Radical)
Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
調査の概要
詳細な説明
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
Subjects will be identified in the Emergency Department of participating hospitals. Samples including nasopharyngeal swab, throat swab, blood, and urine will be obtained.
A case report form for each subject will be completed to include information regarding clinical characteristics, signs and symptoms of infection, presence of complications, and patient outcome. Baseline characteristics including preexisting conditions. Survival data will also be collected for each subject.
Samples collected will be used to characterize the patient's illness as either infectious or not, and if infectious, either bacterial or viral. Samples will also be used to measure changes in gene expression, referred to as the Host Response-Acute Respiratory Illness (HR-ARI) test.
The result of this test will be made in comparison to a retrospective review of the subject's clinical information. Results will not be used for any interventions and will not be released to subjects or their providers.
Because the study procedure includes only sample and data collection, the risks will be minimal and no different than encountered during routine clinical care.
The study was re-assessed in 2020 and applicable updates were made to the record.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
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California
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Davis、California、アメリカ、95616
- The University of California- Davis
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Newton、Massachusetts、アメリカ、02462
- Newton-Wellesley Hospital
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27514
- The University of North Carolina at Chapel Hill
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15224
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Rhode Island/Lifespan
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Texas
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Houston、Texas、アメリカ、77030
- The University of Texas- Houston
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Utah
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Salt Lake City、Utah、アメリカ、84132
- University of Utah Medical Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
A. Age 24 months or older
B. Acute respiratory illness of less than 28 days in duration.
C. Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality:
- Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing
- Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius.
D. Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required.
Exclusion Criteria:
A. Known or suspected infection at any other anatomic site requiring antibacterial therapy.
B. Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Subjects with Acute Respiratory Illness
Patients with acute respiratory illness identified in the Emergency Department
|
comparison to retrospective clinical adjudication
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Positive predictive value with reference standard (PPV)
時間枠：Day 1
|
Number of assay positives that agree with the reference standard / [Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard]
|
Day 1
|
|
Negative predictive value with the reference standard (NPV)
時間枠：Day 1
|
Number of assay negatives that agree with the reference standard / [number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard]
|
Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall agreement with the reference standard (OA)
時間枠：Day 1
|
Number of samples that agree with the reference standard / all samples tested
|
Day 1
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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