PREDICT Citomegalovírus (CMV) (PREDICT CMV)
Monitoramento Imunológico Específico de Citomegalovírus (CMV) Multicêntrico Prospectivo para Prever o Risco do Paciente Após Transplante de Pulmão (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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Toronto, Canadá, M5G 2C4
- Toronto General Hospital: Transplantation
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital: Transplantation
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center: Transplantation
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation: Transplantation
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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).
Descrição
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
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Must be able to understand and provide written informed consent;
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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;
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Undergoing first lung transplant operation;
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Transplant surgery to be performed or performed at enrolling center;
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Concurrent participation in CTOT-20 (Clinical Trials.gov ID: NCT02631720); and
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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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation
Prazo: From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation
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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
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Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant
Prazo: From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant
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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
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Colaboradores e Investigadores
Investigadores
- Cadeira de estudo: Laurie Snyder, MD, MHS, Duke University Medical Center: Transplantation
- Cadeira de estudo: Scott Palmer, MD, MHS, Duke University Medical Center: Transplantation
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Infecções
- Doenças Virais
- Infecções por vírus de DNA
- Infecções Herpesviridae
- Infecções por Citomegalovírus
- Técnicas de investigação
- Terapêutica
- Manipulação de amostras
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Perfurações
- Procedimentos cirúrgicos, operatórios
- Coleção de amostras de sangue
- Métodos
- Flebotomia
Outros números de identificação do estudo
- DAIT CTOT-22
- NIAID CRMS ID#: 38277 (Outro identificador: DAIT NIAID)
Informações sobre medicamentos e dispositivos, documentos de estudo
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