Cell-mediated Immunity for Prevention of CMV Disease

Cytomegalovirus Infections Clinical Trial

Official title:

Monitoring of Specific Cytomegalovirus Cell-mediated Immunity (CMV-CMI) for Optimization of Preventive Strategies Against CMV Infection in High-risk Solid-organ Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538172
• Other study ID #: STCS FUP # 052
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: January 2021

Study information

• Verified date: April 2021
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: January 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old

• Kidney or liver transplantation

• Scheduled to receive CMV antiviral prophylaxis:

• CMV D+/R- patients

• Patients receiving lymphocyte-depleting antibodies (thymoglobulin® or ATG®)

Exclusion Criteria:

• Unable to provide informed consent

• Unable or unwilling to comply with study protocol

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infection

Intervention

Other:
• T-Track® CMV assay

Locations

Country	Name	City	State
Switzerland	Universität Basel	Basel
Switzerland	Universitätsspital Bern	Bern
Switzerland	Hopitaux Universitaires de Genève	Genève
Switzerland	Kantonsspital St.Gallen	St. Gallen
Switzerland	UniversitätsSpital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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 recipien — View Citation

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 predictio — View Citation

Manuel O. Clinical Experience with Immune Monitoring for Cytomegalovirus in Solid-Organ Transplant Recipients. Curr Infect Dis Rep. 2013 Sep 29. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMV infection		one year
Primary	Duration of antiviral prophylaxis		one year
Secondary	Graft survival		one year
Secondary	Incidence of CMV viremia using standardized measure		one year