An Observational Study of Fungal Biomarkers (MK-0000-089)
2015年8月4日 更新者：Merck Sharp & Dohme LLC
A Prospective, Non-Intervention, Observational Assessment of the Correlation Between Circulating Biomarkers of Fungal Bioburden and Clinical Outcome in the Setting of Invasive Aspergillosis
The purpose of this study is to evaluate the relationship between fungal biomarker levels during anti-fungal therapy and the success of treatment for fungal infection.
The primary hypothesis is that over the initial two weeks of anti-fungal therapy, fungal biomarkers from participants with invasive aspergillosis (IA) will be lower for those with a successful clinical outcome compared to those with a failed clinical outcome.
調査の概要
研究の種類
観察的
入学 (実際)
116
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
16年歳以上 (子、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
Participants will be selected through collaborations with clinicians.
説明
Inclusion Criteria:
- Is 16 years of age or older
- Female is either post-menopausal, surgically sterilized, willing to use 2 adequate methods of birth control, or agrees to abstain from heterosexual activity throughout the study
- Female of child bearing potential must have a negative pregnancy test
- Male is surgically sterilized, agrees to use an adequate method of contraception, or agrees to abstain from heterosexual activity for the duration of the study
- Has possible, probable, or confirmed invasive aspergillosis (IA)
- Has had a computed tomography (CT) or magnetic resonance imaging (MRI) scan 72 hours prior to initiation of anti-fungal therapy
Exclusion Criteria:
- Has had hemodialysis using cellulose membrane within 2 weeks of study start
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Invasive Aspergillosis
Observational
|
Blood samples will be collected for 12 weeks to evaluate levels of fungal biomarkers.
|
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 |
|---|---|---|
|
Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-β-D-glucan (βDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6.
時間枠：Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall standard deviation (SD).
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
時間枠：Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
時間枠：Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD.
The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
時間枠：Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD.
The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
時間枠：Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
時間枠：Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD.
The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of %CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
時間枠：Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD.
The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
時間枠：Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
時間枠：Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
時間枠：Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
時間枠：Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
時間枠：Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
時間枠：Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
時間枠：Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
時間枠：Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
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。
スポンサー
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。
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
2009年3月1日
一次修了 (実際)
2011年6月1日
研究の完了 (実際)
2011年8月1日
試験登録日
最初に提出
2009年2月27日
QC基準を満たした最初の提出物
2009年2月27日
最初の投稿 (見積もり)
2009年3月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年8月21日
QC基準を満たした最後の更新が送信されました
2015年8月4日
最終確認日
2015年8月1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
- 0000-089
- 2009_553 (その他の識別子：Merck)
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。
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