French Study In ICU Patients Treated With Tigecycline
2011년 11월 15일 업데이트: Wyeth is now a wholly owned subsidiary of Pfizer
French Prospective Observational Study In Intensive Care Unit (ICU) Patients Treated With Tigecycline
This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned.
Data will be collected only from subjects providing informed consent.
연구 개요
상세 설명
Healthcare visit.
Extension Rationale:
In order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of Basic Results due 26-May-2011 for protocol 3074A1-4448 (B1811030), NCT00799591. Our proposed submission date is 14-Sept-2011.
Pfizer acquired Wyeth on October 16, 2009. With regard to this study, our reconciliation of data identified some discrepancies in data listed in the Project database (managed by the CRO) and the Safety Database (managed by Pfizer). We are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. We are requesting this extension to complete that work so that the data can be treated as final and the CSR can be completed.
연구 유형
관찰
등록 (실제)
156
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Paris, 프랑스, 75018
- Pfizer Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Intensive Care Unit
설명
Inclusion Criteria:
- Adult men and women (18 years).
- Subjects hospitalized in a medical or surgical intensive care unit (ICU) (on the day of enrolment in the study).
- Subjects treated with tigecycline (first, second or third line), said treatment freely chosen by the participating physician, prior to enrollment in the study.
Exclusion Criteria:
- Subjects participating in another biomedical research study.
- Patient (or legal representative) who has not dated or signed informed consent document.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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1
Intensive Care
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Observational study so no intervention in the patient.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
기간: End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event.
Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
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End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit
기간: Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event.
Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
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Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
기간: Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.
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Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Mean Duration (Days) of Treatment With Tigecycline
기간: Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT
기간: Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Combinations of antibiotic treatments for participants treated with clinical success with tigecycline.
Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
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Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit
기간: Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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Combinations of antibiotic treatments for participants treated with clinical success with tigecycline.
Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
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Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture
기간: Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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Microbiological sampling results categorized as a positive blood culture (presence of infection).
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Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination
기간: Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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Microbiological sampling results categorized according to direct examination (identification of the class of germs).
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Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140.
- Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143.
- Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 9월 1일
기본 완료 (실제)
2010년 5월 1일
연구 완료 (실제)
2010년 5월 1일
연구 등록 날짜
최초 제출
2008년 11월 26일
QC 기준을 충족하는 최초 제출
2008년 11월 28일
처음 게시됨 (추정)
2008년 12월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 12월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 11월 15일
마지막으로 확인됨
2011년 9월 1일
추가 정보
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .