Condition category
Infections and Infestations
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
29/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul D Griffiths

ORCID ID

Contact details

Department of Virology
The Royal Free & University Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 (0)20 7830 2997 ext 4951
p.griffiths@medsch.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256119271

Study information

Scientific title

Acronym

Study hypothesis

To determine if quantitative measures of CMV viraemia can be applied to improve the treatment of CMV infection. To evaluate the threshold of CMV viral load for initiation or discontinuation of pre-emptive therapy.

On 29/07/2009 this record was extensively updated. All updates can be found under the relevant field with the above update date. Please also note that the public title 'Optimising the treatment of cytomegalovirus infection' has been updated. The sponsor information has been changed - the initial sponsor was the Department of Health (UK). The trial has also been extended - the initial anticipated end date was 31/12/2003.

Ethics approval

Research Ethics Committee (REC), 20/11/2002, ref: 6077, re-approved on the 16th November following an MHRA audit

Study design

Open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cytomegalovirus (CMV) infection

Intervention

Group A: 72 patients with low level CMV reactivation
Group B: 106 patients receiving pre-emptive therapy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current information as of 29/07/2009:
1. The number of patients in Group A with a low level of CMV reactivation who subsequently develop a viral load greater than 3000 copies/ml.
2, The number of patients in Group B who develop a second episode of a viral load above 3000 copies/ml after therapy has been discontinued at the defined viral load cut-offs.

Initial information at time of registration:
Number of patients receiving another course of therapy because viral load increases above 3000 copies/ml.

Secondary outcome measures

Current information as of 29/07/2009:
1. The duration of antiviral therapy needed to treat CMV viraemia
2. The rate of increase in viral load prior to starting pre-emptive therapy
3. Correlation of viral loads with CMV-specific immune function

Overall trial start date

05/12/2002

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

178 patients in total: stem cell, renal and liver transplant recipients with CMV reactivation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

178

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

05/12/2002

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Virology
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

The Royal Free & University College Medical School - Research and Development (UK)

Sponsor details

Medical School Admin Offices
Room G649
Royal Free & University College Medical School
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7317 7557

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Royal Free Hampstead NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes