Breakthrough CMV Lung Transplant -Multicentre

NCT04439916 | Recruiting

• 1 other identifier: Pro00093295
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Cytomegalovirus (CMV) infection is the most common opportunistic infection in lung transplantation leading to direct and indirect effects that can result in life threatening complications. The risk of CMV infection is highest when the recipient of the transplant has never been in contact with CMV (negative immunity) and the donor had previous contact with CMV (positive immunity). This is called CMV mismatch. For these lung transplant patients 6 to 12 months of prophylaxis with an antiviral called Valganciclovir is recommended. This antiviral can cause side effects like bone marrow toxicity and decrease in immune cells which can result in temporarily having to stop the treatment. Starting and stopping the prophylaxis may result in the CMV becoming resistant to the medication. While taking the prophylaxis it is possible to have a breakthrough of the CMV, this is often due to the development of resistance to the antiviral. The purpose of this study is to learn more about the rate of CMV breakthrough while on prophylaxis after lung transplantation in patients who are CMV mismatch. The investigators will also look at the rates of negative side effects caused by antiviral prophylaxis in this population.

Conditions

Cytomegalovirus Infections

Keywords

CMV; Lung transplant; Valganciclovir

Outcome Measures

Primary Outcomes (1)

• CMV Breakthrough

  Incidence of CMV infection (defined as any quantifiable CMV viral load in plasma or blood) during prophylaxis. Will be categorized as CMV asymptomatic infection or CMV disease.

  Up to 52 weeks

Secondary Outcomes (10)

• CMV infection

  12 weeks

• Neutropenia

  through study completion, up to 64 weeks

• Severe neutropenia

  through study completion, up to 64 weeks

• Leukopenia

  through study completion, up to 64 weeks

• Use of Granulocyte - colony stimulating factor (G-CSF)

  through study completion up, to 64 weeks

Eligibility Criteria

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

Study Population

Lung transplant patients, 18 years or older, who will receive either 6 or 12 months of prophylaxis, are CMV seronegative and received a CMV seropositive transplant.

You may qualify if:

• CMV seronegative recipients of CMV seropositive donor lung transplantation.
• Age 18 years or older.
• Receipt of antiviral prophylaxis with valganciclovir as per local protocol with a duration of 6 or 12 months after transplantation.
• Monitoring of CMV DNAemia post-prophylaxis for at least 12 weeks as per local protocol.
• Signed informed consent.

You may not qualify if:

• Known allergy to ganciclovir or valganciclovir.
• Neutropenia (\< 1.0) pre-transplantation.
• Living-donor lung transplantation.
• Lung re-transplantation.
• Pre-transplant immunodeficiency

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Dr. Carlos Cervera

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Carlos Cervera

CONTACT

780-492-5346; cerveraa@ualberta.ca

Kimberly J Robertson, BSc

CONTACT

780-407-6945; kimberly.robertson2@ahs.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 19, 2020
• Study Start: January 25, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CA (1)