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Cell Mediated Immunity With Risk of Cytomegalovirus (CMV) in Solid Organ Transplant Recipients (ViracorCMI)

2013年4月3日 更新者：Michael Ison

A Study to Correlate CMV-Specific Cell Mediated Immunity With Risk of CMV Disease and With Clinical Response to Therapy Following Solid Organ Transplantation

Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having evidence of having the infection at sometime in their life. Patients who have undergone transplantation are at risk at developing CMV, especially those patients who do not have antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware they have the infection without tests to detect the virus. CMV can less commonly cause serious infections that affect many parts of the body including the intestines, liver, or lungs. In rare cases CMV infection in transplant patients can cause death.

All patients who receive a transplant are monitored for CMV infection. The purpose of this study is to determine if there is a way the investigators can determine in advance which patients are at greatest risk of CMV infection. Specifically, this study will analyze the immune system of transplant patients to determine if there are specific elements of the immune system that 1) helps protect the body against CMV infection, and 2) helps the body combat CMV once it is infected. Identifying these specific elements of the immune system could improve the physician's ability to monitor the SOT patients for CMV infection, and to help treat CMV in those patients that become infected.

調査の概要

状態

完了

条件

詳細な説明

Our hypothesis is that the degree of CMV cell-mediated immune (CMI) response correlates inversely with the risk of development of CMV replication and correlates with the response to initial therapy and risk of relapse after onset of replication. The primary aim of this study is to determine an association between CMV CMI response and both the risk of CMV infection and the degree of initial CMV viremia and rate of viremia clearance with standard CMV therapy. The first secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI and the risk of relapse of CMV disease after initial treatment. The second secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI collected at CMV infection and the following prospective data: Development of CMV end organ disease, resolution of symptoms of CMV infection, other non-CMV infections after initial CMV infection, graft rejection, recurrent or resistant CMV infection, and other markers of immune function. The third secondary aim is to determine an association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI response collected at CMV infection in solid-organ transplant (SOT) recipients and the following retrospective data: Type of SOT, CMV donor/recipient status, type and degree of immunosuppression, type and length of CMV prophylaxis, prior graft rejection and infections (non-CMV).

研究の種類

観察的

入学 (実際)

113

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

  • アメリカ
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Northwestern Memorial Hospital

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

確率サンプル

調査対象母集団

The main study will recruit adult solid organ transplant recipients at Northwestern Memorial Hospital who are CMV donor positive, recipient negative (D+/R-) and SOT recipients at NMH who are CMV recipient positive, irrespective of donor status (D±/R+). A sub-study of this study will enroll up to 50 adult SOT recipients who have quantifiable CMV DNA by PCR and require CMV antiviral therapy, irrespective of their participation in the main study. Patients will be identified prior to transplantation as part of the pre-transplant evaluation process and will be consented either pre-transplant or on the first post-operative day in which they can provide written consent.

説明

Inclusion Criteria:

  • Main Study Subjects will be recruited if they are listed for a SOT (liver, liver-kidney, kidney, kidney-pancreas, cardiac). At the time of transplant, consented patients will have an immediate pre-transplant blood draw for baseline labs subsequent labs will only be drawn if the donor/recipient CMV serostatus is CMV D+/R- (up to a maximum of 50 subjects) or D+/R+ or D-/R+ (up to a maximum of 50 subjects). Subjects must be ≥ 18 years of age, be consentable, and agree to have laboratory and clinical follow-up at Northwestern.
  • CMV Replication Substudy
  • Subjects will be recruited if they have undergone SOT, are found to have a positive CMV QnPCR (> 600 copies/mL) and will be subsequently treated for CMV infection with either intravenous ganciclovir or oral valganciclovir therapy at the discretion of the treating provider. Subjects must be ≥ 18 years of age, able to give consent, and agree to have laboratory and clinical follow-up at Northwestern.

Exclusion Criteria:

  • Subjects will be excluded if they have had a previous history of CMV infection after SOT prior to enrollment (a prior episode of CMV infection or replication prior to the onset of the current episode). Subjects will also be excluded if the subject cannot give informed consent or if the subject is not able to comply with follow-up testing and/or treatment.

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
Main study
Main study patients are enrolled before or at time of solid organ transplant. Qualifying subjects either have tested positive for Cytomegalovirus or have a donor who has tested positive for Cytomegalovirus.
Sub study
Subjects are enrolled to this arm who have begun replicating Cytomegalovirus post transplant. These subjects may or may not have been on the main study arm.

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
Assessment of CMV Cell-Mediated Immune Response
時間枠：For 8 months after transplant or 4 months after clearance of CMV
Association between CMV CMI response and both the risk of CMV infection and the degree of initial CMV viremia and rate of viremia clearance with standard CMV therapy
For 8 months after transplant or 4 months after clearance of CMV

二次結果の測定

結果測定
メジャーの説明
時間枠
Assessment of CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI
時間枠：For 8 months after transplant or 4 months after clearance of CMV

Association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI collected at CMV infection and the following prospective data:

  • Development of CMV end organ disease
  • Resolution of symptoms of CMV infection
  • Other non-CMV infections after initial CMV infection
  • Graft rejection
  • Recurrent or resistant CMV infection
  • Other markers of immune function
  • Type of SOT
  • CMV donor/recipient status
  • Type and degree of immunosuppression
  • Type and length of CMV prophylaxis
  • Prior graft rejection and infections (non-CMV)
For 8 months after transplant or 4 months after clearance of CMV

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

Michael Ison

協力者

ViraCor Laboratories

捜査官

  • 主任研究者：Michael G Ison, MD,MS、Northwestern University

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

2010年4月1日

一次修了 (実際)

2011年12月1日

研究の完了 (実際)

2012年3月1日

試験登録日

最初に提出

2012年3月14日

QC基準を満たした最初の提出物

2012年3月16日

最初の投稿 (見積もり)

2012年3月20日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年4月5日

QC基準を満たした最後の更新が送信されました

2013年4月3日

最終確認日

2013年4月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • NU-ViraCor 001

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