サイトメガロウイルス (CMV) を予測する (PREDICT CMV)
肺移植後の患者のリスクを予測するための前向き多施設サイトメガロウイルス (CMV) 特異的免疫モニタリング (CTOT-22)
The overall objective of this study is to establish a personalized test to measure individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an effort to guide antiviral prophylaxis duration in clinical practice.
Targeted participants are those:
- enrolled in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who
- are CMV recipient positive by serology as determined using methods in accordance with current local organ procurement organization policies.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Cytomegalovirus (CMV) is a common virus. The virus is spread from one person to another through infected body fluids. In those with a normal immune system, CMV does not cause much of a problem. The immune system keeps the virus under control so most people do not have any symptoms. Once infected, the virus usually stays dormant (inactive) in the body for a person's entire life. This means some of the cells in the body are infected and the virus can become active again.
Lung transplant recipients take anti-rejection medicines to prevent the body from rejecting the transplanted lung(s). Although anti-rejection medications help protect the transplanted lung(s) from the body's immune system, these medications also decrease the body's ability to fight infections. This reduces the immune system's ability to control viruses like CMV. Many transplant recipients take an antiviral medication early after transplant to help the body control the CMV virus. This is the time that risk of infection would be highest. Sometimes recipients get an active CMV infection after stopping these medicines. If this happens, the infection is treated and monitored.
In this study, investigators are trying to determine whether a blood test can predict development of active CMV infection in lung transplant recipients. Specifically, the clinical research study will prospectively assess the performance of an immune signature based on the "ex vivo" measurement of T cell CMV specific immunity in predicting freedom from future CMV infections among recipient positive (R+) lung transplant participants receiving standard durations of valganciclovir prophylaxis.
研究の種類
研究の種類
入学 (実際)
入学
連絡先と場所
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Hospital: Transplantation
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- Duke University Medical Center: Transplantation
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation: Transplantation
-
-
-
-
-
Toronto、カナダ、M5G 2C4
- Toronto General Hospital: Transplantation
-
-
参加基準
適格基準
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
Adult lung transplant recipients undergoing lung transplant at one of the four participating centers and concurrently enrolled in CTOT-20 (Clinical Trials.gov ID: NCT02631720).
説明
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
-
Must be able to understand and provide written informed consent;
-
Anticipated listing for lung transplantation OR listed for lung transplant OR is within 45 days of having received a single or bilateral cadaveric donor lung transplant;
-
Undergoing first lung transplant operation;
-
Transplant surgery to be performed or performed at enrolling center;
-
Concurrent participation in CTOT-20 (Clinical Trials.gov ID: NCT02631720); and
-
CMV-seropositive lung transplant recipient, using methods in accordance with current local organ procurement organization policies.
- Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Exclusion Criteria:
Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Unwilling to enroll in CTOT-20 (Clinical Trials.gov ID: NCT02631720);
- Multi-organ recipient;
- Prior recipient of any solid organ transplant, including prior lung transplant;
- Prior or concurrent recipient of bone marrow transplant;
- Human Immunodeficiency Virus (HIV) infection;
- Pregnant or planned pregnancy;
- Any condition that, in the investigator's opinion, would make it unlikely for the recipient to complete follow up procedures or complete the study; or
- Participation in an investigational drug trial at the time of enrollment visit.
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：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
|
CMV+ First Lung Transplant Recipients
Participants enrolled in one of four North American sites in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who are cytomegalovirus positive by serology (e.g., CMV Recipient positive). |
Serial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation
時間枠：From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation
|
Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation. |
From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation
|
|
Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant
時間枠：From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant
|
Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation. |
From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant
|
協力者と研究者
スポンサー
スポンサー
協力者
協力者
捜査官
捜査官
- スタディチェア：Laurie Snyder, MD, MHS、Duke University Medical Center: Transplantation
- スタディチェア：Scott Palmer, MD, MHS、Duke University Medical Center: Transplantation
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)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- DAIT CTOT-22
- NIAID CRMS ID#: 38277 (その他の識別子：DAIT NIAID)
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
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