Dynamic Infection Kinetics for Early Diagnosis, Monitoring, and Prognostication of Sepsis in Adult Oncology Patients: Evaluating Serial Infection Biomarkers, Blood Culture Kinetics, Treatment Response, Disease Severity, and Clinical Outcomes
Dynamic Infection Kinetics as an Early Diagnostic and Monitoring Tool for Sepsis in Oncology Patients
Dynamic Infection Kinetics as an Early Diagnostic and Monitoring Tool for Sepsis in Oncology Patients
This study aims to evaluate whether changes over time in infection-related biomarkers and blood culture findings can help detect sepsis earlier and monitor the response to treatment in adult patients with cancer.
Cancer patients are at increased risk of developing serious infections and sepsis because of their underlying disease and its treatment. Early diagnosis and monitoring can be challenging because the signs and laboratory findings of infection may be nonspecific.
This prospective observational cohort study will include adult oncology patients with suspected sepsis who have at least one blood culture collected as part of their routine medical care. Clinical, laboratory, and microbiological information will be collected, including blood culture results, causative microorganisms, time to blood culture positivity, blood culture clearance time, C-reactive protein (CRP), procalcitonin (PCT), presepsin, absolute neutrophil count, serum lactate, and clinical severity measures.
Patients will be followed during hospitalization and for up to 30 days after enrollment. The study will assess whether changes in these markers over time are associated with treatment response, persistent infection, complications, intensive care admission, and mortality.
The findings may help identify patients at higher risk of poor outcomes and may contribute to improved monitoring and management of sepsis in patients with cancer.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Sohag Governorate
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Sohag、Sohag Governorate、エジプト
- 募集
- Sohag Oncology Center
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コンタクト:
- Esraa Mohamed Abdelraheem, Demonstrator
- 電話番号:0201097937788
- メール:Esraa_Abdelraheem@med.sohag.edu.eg
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Confirmed diagnosis of a solid or hematological malignancy.
- Clinical suspicion of sepsis according to treating physicians.
- At least one blood culture obtained before or shortly after initiation of antimicrobial therapy.
- Availability for clinical follow-up during hospitalization.
Exclusion Criteria:
- Patients receive palliative care only.
- Absence of blood culture sampling.
- Incomplete clinical or laboratory data.
- Refusal to participate in the study, when applicable.
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 |
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Oncology Patients with Suspected Sepsis
Adult oncology patients with suspected sepsis who have at least one blood culture obtained as part of routine clinical care.
Participants will be followed during hospitalization and for up to 30 days after enrollment.
Clinical, laboratory, and microbiological data will be collected to evaluate dynamic infection kinetics and their association with treatment response and clinical outcomes.
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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 |
時間枠 |
|---|---|
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30-day all-cause mortality
時間枠:Within 30 days after enrollment
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Within 30 days after enrollment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- Soh-Med-26-7-29MS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
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