Cell Mediated Immunity With Risk of Cytomegalovirus (CMV) in Solid Organ Transplant Recipients (ViracorCMI)
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.
Studieoversigt
Status
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Assessment of CMV Cell-Mediated Immune Response
Tidsramme: For 8 months after transplant or 4 months after clearance of CMV
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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
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For 8 months after transplant or 4 months after clearance of CMV
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI
Tidsramme: For 8 months after transplant or 4 months after clearance of CMV
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Association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI collected at CMV infection and the following prospective data:
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For 8 months after transplant or 4 months after clearance of CMV
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael G Ison, MD,MS, Northwestern University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- NU-ViraCor 001
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