ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000551897

Ethics application status

Approved

Date submitted

7/05/2012

Date registered

24/05/2012

Date last updated

18/12/2018

Date data sharing statement initially provided

18/12/2018

Date results provided

18/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Measuring cytomegalovirus (CMV) immunity to direct optimal length of CMV prophylaxis following lung transplantation.

Scientific title

In lung transplant recipients at risk of cytomegalovirus reactivation how does QuantiFERON-CMV directed cytomegalovirus prophylaxis compare to standard of care cytomegalovirus prophylaxis to reduce the incidence of late onset cytomegalovirus infection.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1129-8079

Trial acronym

None

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lung Transplantation

Cytomegalovirus

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Comparator / control treatment

Standard Treatment – cessation of antiviral prophylaxis (valganciclovir 450mg twice daily) at 5 months post-transplant.

Control group

Active

Outcomes

Primary outcome [1]

The effectiveness of QuantiFERON-CMV directed antiviral prophylaxis on the incidence of CMV reactivation within the lung allograft in patients at-risk of CMV reactivation. CMV reactivation within the lung allograft will be assessed as the presence of CMV in the BAL, deifined as greater than or equal to 600 copies.

Timepoint [1]

Within 18 months of transplant

Secondary outcome [1]

Compare the need for intravenous ganciclovir in both arms of the study. The need for intravenous ganciclovir will be assessed by the presciption for, the incidence of use and the duration of treatment in all study participants.

Timepoint [1]

Within 18 months of transplant

Secondary outcome [2]

Evaluate the incidence of ganciclovir resistance in all study patients. The incidence of ganciclovir resistance will be based on the clinical evaulation by the treating physician and documented in the source documents. The incidence of patients with ganciclovir resistence documented will be collected in all participants.

Timepoint [2]

Within 18 months of tranpslant

Secondary outcome [3]

Evaluate the presence of CMV-specific immunity. QFN-CMV assay will be tested on all study patients at 5, 8 & 11 months post transplant. The QFN-CMV assay will identify the presence of CMV-specific immunity in all study participants will enable this outcome to be assessed.

Timepoint [3]

At 5, 8 and 11 months post tranpslant

Secondary outcome [4]

Evaluate the incidence of acute cellular rejection. Acute cellular rejection will be defined by as a Lung Biopsy Grade greater than or equal to A1 (as defined by ISHLT). Lung biospy and assessment for acute cellular rejection occur routinely in the first 18 months of tranpslant, and the incidence of this will be collected in all patients.

Timepoint [4]

Within 18 months of tranpslant

Secondary outcome [5]

Assess frequency of side effects from antiviral therapy. Some of the known side effects to valganciclovir include diarrhoea, nausea, fevers, headaches, fatigue, hypertension, infection, neutropaenia, anaemia, decreased fertility, tremor, and there may be other less common or unreproted possible side effects. All participants will have their source notes reviewed for the above side effects, and these will be recorded in the adverse event log of the case report forms for evaulation.

Timepoint [5]

Within 18 months of transplant

Secondary outcome [6]

Evaluate survival.

Timepoint [6]

Within 18 months of tranpslant

Secondary outcome [7]

Evaluate the incidence of BOS. BOS is a physiological assessment of lung function as measured by spirometry, as defined by ISHLT. BOS is present if there is 20% drop in lung fuction compared to the best lung function achieved following lung transoplantation, in the absence of other reversible causes.

Timepoint [7]

Within 18 months of transplant

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/06/2012

Actual

20/06/2012

Date of last participant enrolment

Anticipated

Actual

18/03/2016

Date of last data collection

Anticipated

Actual

30/04/2017

Sample size

Target

210

Accrual to date

Final

119

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

Commercial Road
Melbourne
Victoria 3004

Country [1]

Australia

Primary sponsor type

Hospital

Name

Dr Glenn Westall, for The Alfred Hospital

Address

Department AIRMed,
5th Floor, Alfred Hospital
Commercial Road
Melbourne
Victoria 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Hospital Ethic Committee

Ethics committee address [1]

Dept of Ethics and Research
The Alfred Hospital
Commercial Road 
Melbourne 
Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/05/2012

Ethics approval number [1]

83-12

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Glen Westall

Address

The Alfred Hospital, Dept of AIRMed, Commercial Road, Melbourne, VICTORIA, 3004

Country

Australia

Phone

+ 61 3 9076 2000

Fax

+ 61 3 9076 8225

g.westall@alfred.org.au

Contact person for public queries

Name

Dr Glen Westall

Address

The Alfred Hospital
Dept of AIRMed
Commercial Road
Melbourne
Victoria 3004

Country

Australia

Phone

+61 3 9076 2000

Fax

g.westall@alfred.org.au

Contact person for scientific queries

Name

Dr Glen Westall

Address

The Alfred Hospital
Dept of AIRMed
Commercial Road
Melbourne
Victoria 3004

Country

Australia

Phone

+61 3 9076 2000

Fax

g.westall@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD sharing is not approved under the current Ethics Approval.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A Randomized Study of Quantiferon CMV-directed Versus Fixed-duration Valganciclovir Prophylaxis to Reduce Late CMV after Lung Transplantation.	2019	https://dx.doi.org/10.1097/TP.0000000000002454

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically