Personalized Needs in Clostridium Difficile Infections (SPECIFY)
Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Athens, 그리스, 10676
- 5th Department of Internal Medicine, Evangelismos Athens General Hospital
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Athens, 그리스, 11527
- 1st Department of Internal Medicine, "G.Gennimatas" General hospital
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Athens, 그리스, 11527
- 1st Department of Internal Medicine, Laikon General Hospital
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Athens, 그리스, 11527
- 3rd Department of Internal Medicine, Sotiria General Hospital
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Athens, 그리스, 12462
- 4th Department of Internal Medicine, Attikon University Hospital
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Athens, 그리스, 15126
- 2nd Department of Internal Medicine, Sismanogleion General Hospital
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Magoula, 그리스, 10918
- 1st Department of Internal Medicine, Thriassio General Hospital
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Magoula, 그리스, 10918
- 2nd Department of Internal Medicine, Thriasio General Hospital
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Maroúsi, 그리스, 15123
- 2nd Department of Oncology, Mitera Hospital
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Piraeus, 그리스
- Infections Unit Tzaneion General Hospital
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Pátra, 그리스, 36504
- Department of Internal Medicine, Patras University Hospital
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Thessaloniki, 그리스, 54248
- 1st Department of Internal Medicine, AHEPA University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Clostridium difficile infection
Patients with Clostridium difficile-associated diarrhea for development of biomarkers
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Blood sampling
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Definition of prognostic biomarker
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Athanasios Skoutelis, MD, Evangelismos Athens General Hospital
- 연구 의자: Evangelos J Giamarellos-Bourboulis, MD, PhD, Attikon Hospital
- 수석 연구원: George Chrysos, MD, PhD, Tzaneion Piraeus General Hospital
- 수석 연구원: Styliani Symbardi, MD, PhD, Thriassio Elefsis General Hospital
- 수석 연구원: Zoi Alexiou, MD, PhD, Thriassio Elefsis General Hospital
- 수석 연구원: Kostantinos Syrigos, MD, PhD, Sotiria General Hospital
- 수석 연구원: George Daikos, MD, PhD, Laikon Athens General Hospital
- 수석 연구원: Panagiotis Gargalianos, MD, PhD, G.Gennimatas Athens General Hospital
- 수석 연구원: Malvina Lada, MD, PhD, Sismanogleion General Hospital
- 수석 연구원: Charalambos Gogos, MD, PhD, University Hospital of Patras
- 수석 연구원: Ilias Athanasiadis, MD, PhD, Mitera General Hospital
- 수석 연구원: Symeon Metallidis, MD, PhD, AHEPA Thessaloniki University Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CL01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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