French Study In ICU Patients Treated With Tigecycline
2011年11月15日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
156
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Paris、フランス、75018
- Pfizer Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Intensive Care Unit
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 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 |
|---|---|
|
1
Intensive Care
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Observational study so no intervention in the patient.
|
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 |
|---|---|---|
|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
時間枠：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
時間枠：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
|
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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
時間枠：Baseline (Inclusion) through last dose of study treatment or up to 25 months
|
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
時間枠：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
時間枠：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
時間枠：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
|
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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年9月1日
一次修了 (実際)
2010年5月1日
研究の完了 (実際)
2010年5月1日
試験登録日
最初に提出
2008年11月26日
QC基準を満たした最初の提出物
2008年11月28日
最初の投稿 (見積もり)
2008年12月1日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年12月19日
QC基準を満たした最後の更新が送信されました
2011年11月15日
最終確認日
2011年9月1日
詳しくは
本研究に関する用語
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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。