A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children
A Cohort Study to Evaluate Biomarkers as Indicator for the Infectious Source of Sepsis Through a Blood Test
調査の概要
詳細な説明
The purpose of this prospective, non-interventional study is to develop and validate a blood gene expression test for diagnosing the cause of sepsis in adults and children with symptoms of infection.
Sepsis affects 31.5 million people globally leading to 5.3 million deaths each year. Sepsis is particularly harmful to immunodeficient patients undergoing cancer therapy with 3.7 percent to 6.4 percent of cancer patients diagnosed with sepsis in the US in their first year after cancer diagnosis. Current tests to diagnose the infectious cause of sepsis rely on blood cultures which takes 24-48 hours to complete; leading to delays in early treatment critical to reduce the risk of developing sepsis shock and possibly death. In addition, around 50 percent of severe sepsis cases are culture negative, confounded acute infections not detected in the blood, by viral infection or uninfected patients exhibiting systemic inflammatory response syndrome (SIRS). Since sepsis often progresses to sepsis shock within 72 hours, suspected sepsis cases are usually immediately treated with antibiotics until results from testing distinguish the cause of symptoms. This leads to the over-use of antibiotics and delays appropriate treatment for those without bacterial infection or un-infected SIRS.
A quick and accurate diagnostic blood test may enable early discrimination of the cause of sepsis resulting in faster more appropriate treatments and reduced sepsis complications and death.
The study will collect blood samples from participants presenting symptoms of acute infection, without co-morbidities and follow symptom severity and mortality for 28 days.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:James Schilling
- 電話番号:650479198
- メール:admin@mprobe.com
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
Criteria: Inclusion Criteria:
- Clinical suspicion of an acute infectious disease
Presence of at least ONE of the following:
- Temperature ≥ 38°C or Temperature ≤ 36°C
- Heart rate > 90 bpm
- Respiratory rate > 20/min
- Self reported fever/chills
- Symptom duration ≤ 7 days
Exclusion Criteria:
- Received antibiotics or antivirals in the past 2 weeks.
- Previous infection in previous 2 weeks
- Primary or secondary immunodeficiency
- Proven or suspected HIV, hepatitis B or hepatitis C infection
- Current immune-suppressive or immune-modulating treatment
- Active hematological malignancy
- Other illnesses that affect life expectancy
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
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 |
---|---|---|
Diagnosis of underlying cause of sepsis infection
時間枠:1 month
|
The sensitivity and specificity of the assay in differentiating bacterial from viral infection.
|
1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Diagnosis of underlying cause of acute infection symptoms
時間枠:1 month
|
The sensitivity and specificity of the assay in differentiating infectious and non-infectious disease.
|
1 month
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jia Huang、The Second Afliated Hospital of Southern University of Science and Technology
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
本研究に関する用語
キーワード
その他の研究ID番号
- Sepsis_001
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
Diagnostic Test: Blood specimen collectionの臨床試験
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London School of Hygiene and Tropical MedicineHealthNet TPO; Health Protection and Research Organisation; Medical Emergency Relief International完了