Breakthrough CMV Lung Transplant -Multicentre

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Known allergy to ganciclovir or valganciclovir.

Neutropenia (< 1.0) pre-transplantation.

Living-donor lung transplantation.

Lung re-transplantation.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
Up to 52 weeks

Secondary outcomes

1

CMV infection

Incidence of CMV infection post-prophylaxis (categorized as CMV infection or disease).

Time frame
12 weeks
2

Neutropenia

Absolute neutrophil count \< 1,000 cells/mL

Time frame
through study completion, up to 64 weeks
3

Severe neutropenia

Absolute neutrophil count \< 500 cells/mL

Time frame
through study completion, up to 64 weeks
4

Leukopenia

White cell count \< 2,000 cells/mL

Time frame
through study completion, up to 64 weeks

Other outcomes

Sponsors and contacts

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