None listed
Conditions
Brief summary
After lung transplantation, all patients receive medications, called immunosuppressives. These drugs suppress the immune system and prevent the body from rejecting the transplanted lung(s), but this also makes them susceptible to infections. CMV is a virus known to cause infection after transplantation and affects over 40% of patients and may influence the on-going success of their new lung(s). To reduce the damage that CMV can cause in newly transplanted lungs, all patients undergoing lung transplantation take medications, called anti-virals (Valganciclovir), for approximately the first five months following the transplant operation. Valganciclovir is approved in Australia for use to reduce CMV infection after lung transplantation. However, CMV infection can occur after the anti-viral drugs are stopped. The purpose of this project is to see whether a blood test (QuantiFERON-CMV assay) that assesses whether you can mount an immune response against CMV, can predict which patients are at risk of ongoing CMV infection, and therefore would benefit from taking the anti-viral medication (Valganciclovir) for a longer period.
Interventions
The intervention involves directing patient care according to the results of the patients QuantiFERON-CMV blood test. At 5 months post lung transplant patients will be randomised to receive (1) standard of care - cessation of antiviral prophylaxis at 5 months post-transplant, or (2) QuantiFERON-CMV directed care - where patients prophylaxis will be individualised according to their blood results, with their first QFN-CMV assay being taken at their 5 month visit. If the QFN-CMV assay is positive
The intervention involves directing patient care according to the results of the patients QuantiFERON-CMV blood test. At 5 months post lung transplant patients will be randomised to receive (1) standard of care - cessation of antiviral prophylaxis at 5 months post-transplant, or (2) QuantiFERON-CMV directed care - where patients prophylaxis will be individualised according to their blood results, with their first QFN-CMV assay being taken at their 5 month visit. If the QFN-CMV assay is positive, the patients will cease antiviral prophylaxis, if the QFN-CMV assay is negative, the patients will receive a further 3 months antiviral prophylaxis (valganciclovir 450mg tablet orally twice daily). The QFN-CMV assay will be repeated at 8 months post-transplant, if positive, cease antiviral prophylaxis, if negative continue a further 3 months antiviral prophylaxis (valganciclovir 450mg tablet orally twice daily). The QFN-CMV assay will be repeated for a final time at 11 months post transplant, and regardless of results, the patient will cease antiviral prophylaxis.
Sponsors
Dr Glenn Westall, for The Alfred Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult (greater than or equal to 18yrs) lung transplant recipients, who are at risk of CMV reactivation, and who have provided written informed consent.
Exclusion criteria
(1) CMV seronegative recipient and seronegative donor, (2) known ganciclovir resistance, (3) valganciclovir-related neutropenia, (4) BOS grad 3 or BOS with unstable FEV1, (5) hospitalized requiring intubation or mechanical ventilation, (6) active treatment for acute graft rejection, (7) pregnant, lactating, or breast feeding, (8) known hypersensitivity to valganciclovir, or (9) any other condition in the investigators medical opinion that precludes the patients participation.
Outcome results
None listed