Cell-mediated Immunity for Prevention of CMV Disease

NCT02538172 | Completed

• 1 other identifier: STCS FUP # 052
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 5

Brief Summary

An open-label randomized controlled trial to adapt the duration of antiviral prophylaxis in D+/R- patients and in R+ patients receiving ATG according to the result of the T-Track® CMV assay. Investigators will include kidney and liver transplant recipients. Patients will be randomized during the first month post transplant. In the interventional arm, while the patient is on antiviral prophylaxis, CMI will be monitored every 4 weeks from the 2nd month after transplant. Measurement of CMV CMI will be done in real time by using the T-Track® CMV assay. The continuation of antiviral prophylaxis will depend on the result of the assay:

• T-Track positive (patient at lower risk): discontinuation of the antiviral drug
• T-Track negative (patient at higher risk): continuation of the antiviral drug until the maximal duration of prophylaxis (3 to 6 months) The standard arm will receive a standard fixed duration of antiviral prophylaxis (3 months for R+ thymoglobulin treated-patients and 6 months for D+/R- patients). Measurement of CMV CMI by both T-Track® CMV and the Quantiferon-CMV® assays will be done at the same time points of the interventional arm, but the result will not be known by the investigators. After discontinuation of prophylaxis, patients in both arms will be followed for the development of CMV replication at each visit using the local PCR assay and antiviral therapy will be administered in case of CMV infection according to local guidelines. The co-primary endpoints will be the incidence of CMV disease or antiviral-treated CMV replication during the first 12 months post transplant AND the duration of antiviral prophylaxis.

Conditions

Cytomegalovirus Infections

Keywords

Cell-mediated immunity; Antiviral prophylaxis; Transplantation

Outcome Measures

Primary Outcomes (2)

• Incidence of CMV infection

  one year

• Duration of antiviral prophylaxis

  one year

Secondary Outcomes (2)

• Graft survival

  one year

• Incidence of CMV viremia using standardized measure

  one year

Study Arms (2)

Intervention

EXPERIMENTAL

T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir

Other: T-Track® CMV assay

Control

OTHER

T-Track® CMV assay Quantiferon-CMV® assays Valganciclovir

Other: T-Track® CMV assay

Interventions

T-Track® CMV assay OTHER

Also known as: Quantiferon-CMV® assays, Valganciclovir

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• years old
• Kidney or liver transplantation
• Scheduled to receive CMV antiviral prophylaxis:
• CMV D+/R- patients
• Patients receiving lymphocyte-depleting antibodies (thymoglobulin® or ATG®)

You may not qualify if:

• Unable to provide informed consent
• Unable or unwilling to comply with study protocol

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (5)

Universität Basel

Basel, 4051, Switzerland

Location

Universitätsspital Bern

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (4)

• 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 RESULT

• Manuel O. Clinical Experience with Immune Monitoring for Cytomegalovirus in Solid-Organ Transplant Recipients. Curr Infect Dis Rep. 2013 Sep 29. doi: 10.1007/s11908-013-0369-6. Online ahead of print.

  PMID: 24078428 RESULT

• Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.

  PMID: 20353469 RESULT

• Manuel O, Laager M, Hirzel C, Neofytos D, Walti LN, Hoenger G, Binet I, Schnyder A, Stampf S, Koller M, Mombelli M, Kim MJ, Hoffmann M, Koenig K, Hess C, Burgener AV, Cippa PE, Hubel K, Mueller TF, Sidler D, Dahdal S, Suter-Riniker F, Villard J, Zbinden A, Pantaleo G, Semmo N, Hadaya K, Enriquez N, Meylan PR, Froissart M, Golshayan D, Fehr T, Huynh-Do U, Pascual M, van Delden C, Hirsch HH, Juni P, Mueller NJ; Swiss Transplant Cohort Study (STCS). Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial. Clin Infect Dis. 2024 Feb 17;78(2):312-323. doi: 10.1093/cid/ciad575.

  PMID: 37738676 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oriol Manuel, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Privat-Docent (PD)

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 2, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CH (5)