Quantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients

NCT00817908 | Completed

• 1 other identifier: 7267
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.

Conditions

Cytomegalovirus Infection

Keywords

liver transplant; lung transplant; kidney transplant; heart transplant; CMV CMI; Transplant

Study Arms (1)

1

Patients at high risk for CMV infection (CMV serostatus: D+/R-) who are expected to receive three months of antiviral prophylaxis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will aim to enrol 120 D+/R- transplant patients.

You may qualify if:

• CMV D+/R- liver, kidney, heart, pancreas, lungor combined transplant recipients
• All eligible patients must be scheduled to receive 3 months of either valganciclovir, oral ganciclovir, or intravenous ganciclovir prophylaxis.
• Able to give written informed consent
• Are willing and able to comply with the protocol
• Age \>=18 years

You may not qualify if:

• \- Patient unwilling or unable to give informed consent

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G-2E1, Canada

Location

Related Publications (5)

• Razonable RR, Rivero A, Rodriguez A, Wilson J, Daniels J, Jenkins G, Larson T, Hellinger WC, Spivey JR, Paya CV. Allograft rejection predicts the occurrence of late-onset cytomegalovirus (CMV) disease among CMV-mismatched solid organ transplant patients receiving prophylaxis with oral ganciclovir. J Infect Dis. 2001 Dec 1;184(11):1461-4. doi: 10.1086/324516. Epub 2001 Oct 23.

  PMID: 11709790 BACKGROUND

• Lowance D, Neumayer HH, Legendre CM, Squifflet JP, Kovarik J, Brennan PJ, Norman D, Mendez R, Keating MR, Coggon GL, Crisp A, Lee IC. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. International Valacyclovir Cytomegalovirus Prophylaxis Transplantation Study Group. N Engl J Med. 1999 May 13;340(19):1462-70. doi: 10.1056/NEJM199905133401903.

  PMID: 10320384 BACKGROUND

• Flechner SM, Avery RK, Fisher R, Mastroianni BA, Papajcik DA, O'Malley KJ, Goormastic M, Goldfarb DA, Modlin CS, Novick AC. A randomized prospective controlled trial of oral acyclovir versus oral ganciclovir for cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Transplantation. 1998 Dec 27;66(12):1682-8. doi: 10.1097/00007890-199812270-00019.

  PMID: 9884259 BACKGROUND

• Paya C, Humar A, Dominguez E, Washburn K, Blumberg E, Alexander B, Freeman R, Heaton N, Pescovitz MD; Valganciclovir Solid Organ Transplant Study Group. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2004 Apr;4(4):611-20. doi: 10.1111/j.1600-6143.2004.00382.x.

  PMID: 15023154 BACKGROUND

• Manuel O, Husain S, Kumar D, Zayas C, Mawhorter S, Levi ME, Kalpoe J, Lisboa L, Ely L, Kaul DR, Schwartz BS, Morris MI, Ison MG, Yen-Lieberman B, Sebastian A, Assi M, Humar A. Assessment of cytomegalovirus-specific cell-mediated immunity for the prediction of cytomegalovirus disease in high-risk solid-organ transplant recipients: a multicenter cohort study. Clin Infect Dis. 2013 Mar;56(6):817-24. doi: 10.1093/cid/cis993. Epub 2012 Nov 29.

  PMID: 23196955 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Atul Humar, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: January 7, 2009
• Study Start: May 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

CA (1)