Personalized Needs in Clostridium Difficile Infections (SPECIFY)
Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy
調査の概要
詳細な説明
Medical world is nowadays witnessing a sudden increase of the incidence of infections by Clostridium difficile (DCI). This is due in part to the prolongation of survival of patients with major comorbidities like solid tumor malignancies and lymphomas but also to the widespread intake of proton pump inhibitors and of wide-spectrum antimicrobials. It is highly probable that isolates of C.define causing this pandemic are genetically different than isolates of the same species predominating 20 years ago. This hypothesis is developed based on data of the epidemiology of CDI: in old times administration of clindamycin and ampicillin were the main drivers of CDI; recent studies report fluoroquinolones, 2nd and 3rd generation cephalosporins and even vancomycin (i.e. a drug of choice for CDI) to be linked with the development of CDI.
One major hurdle in management of CDI is relapse; the risk of relapse is reported as 15-20% after the first episode; however it is geometrically increased to even 60-80% after the second episode. As a consequence, management of CDI becomes a major health problem.
Fidaxomicin is a novel compound active against species of C.dificille. Results of two recent double-blind, randomized, large scale clinical studies have shown that oral treatment for 10 days with fidaxomicin 200mg bid was non-inferior to oral treatment with vancomycin 125mg q6h. However, the risk of relapse after treatment with vancomycin was close to 25% and with fidaxomicin close to 15%. This difference was statistically significant in both trials outscoring the superiority of fidaxomicin over vancomycin for the management of CDI. Moreover, meta-analysis has shown a significant reduction in mortality by fidaxomicin.
Despite proven superiority, prescription of fidaxomicin is limited to few cases mostly due to high cost. In many countries prescription is restricted to cases of relapsing CDI. Clinical feeling coming both from post-marketing experience as well as from published evidence supports the use of fidaxomicin for cases with risk of death and overt risk of relapse. However, molecular analysis of the C.difficile pathogen cannot be used as a tool for the prediction of relapse since in relapse cases pathogens carry less than 2 single nucleotide variants of the initial isolate. SPECIFY is aiming to develop a score using both clinical and genetic and biomarker data that can efficiently discriminate patients at risk of severe CDI and at risk of relapse of CDI. This score can become in future a tool to discriminate patients at need for treatment with fidaxomicin instead of traditional treatment with metronidazole/vancomycin.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Athens、ギリシャ、10676
- 5th Department of Internal Medicine, Evangelismos Athens General Hospital
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Athens、ギリシャ、11527
- 1st Department of Internal Medicine, "G.Gennimatas" General hospital
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Athens、ギリシャ、11527
- 1st Department of Internal Medicine, Laikon General Hospital
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Athens、ギリシャ、11527
- 3rd Department of Internal Medicine, Sotiria General Hospital
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Athens、ギリシャ、12462
- 4th Department of Internal Medicine, Attikon University Hospital
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Athens、ギリシャ、15126
- 2nd Department of Internal Medicine, Sismanogleion General Hospital
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Magoula、ギリシャ、10918
- 1st Department of Internal Medicine, Thriassio General Hospital
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Magoula、ギリシャ、10918
- 2nd Department of Internal Medicine, Thriasio General Hospital
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Maroúsi、ギリシャ、15123
- 2nd Department of Oncology, Mitera Hospital
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Piraeus、ギリシャ
- Infections Unit Tzaneion General Hospital
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Pátra、ギリシャ、36504
- Department of Internal Medicine, Patras University Hospital
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Thessaloniki、ギリシャ、54248
- 1st Department of Internal Medicine, AHEPA University Hospital
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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:
- Age equal to or more than 18 years
- Both genders
- Diarrhea defined as at least 3 episodes of unformed stools in the last 24 hours according to the Bristol stool chart
- Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.
Exclusion Criteria:
1. No exclusion criteria exist
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
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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Clostridium difficile infection
Patients with Clostridium difficile-associated diarrhea for development of biomarkers
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Blood sampling
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Definition of prognostic biomarker
時間枠：12 months
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Patients with positive score and unfavorable outcome.
Unfavorable outcome is defined as at least one of the following: a) number of patients with severe infection at disease onset; b) number of patients who progress into severe infection; c) number of patients with disease recurrence; and d) number of patients who die
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12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Athanasios Skoutelis, MD、Evangelismos Athens General Hospital
- スタディチェア：Evangelos J Giamarellos-Bourboulis, MD, PhD、Attikon Hospital
- 主任研究者：George Chrysos, MD, PhD、Tzaneion Piraeus General Hospital
- 主任研究者：Styliani Symbardi, MD, PhD、Thriassio Elefsis General Hospital
- 主任研究者：Zoi Alexiou, MD, PhD、Thriassio Elefsis General Hospital
- 主任研究者：Kostantinos Syrigos, MD, PhD、Sotiria General Hospital
- 主任研究者：George Daikos, MD, PhD、Laikon Athens General Hospital
- 主任研究者：Panagiotis Gargalianos, MD, PhD、G.Gennimatas Athens General Hospital
- 主任研究者：Malvina Lada, MD, PhD、Sismanogleion General Hospital
- 主任研究者：Charalambos Gogos, MD, PhD、University Hospital of Patras
- 主任研究者：Ilias Athanasiadis, MD, PhD、Mitera General Hospital
- 主任研究者：Symeon Metallidis, MD, PhD、AHEPA Thessaloniki University Hospital
出版物と役立つリンク
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- CL01
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?
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
米国で製造され、米国から輸出された製品。
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