Determining a viral load threshold for pre-emptive therapy for cytomegalovirus infection in transplant patients using real time PCR monitoring

ISRCTN	ISRCTN03307563
DOI	https://doi.org/10.1186/ISRCTN03307563
ClinicalTrials.gov (NCT)	NCT00947141
Protocol serial number	N0256119271
Sponsor	The Royal Free & University College Medical School - Research and Development (UK)
Funder	The Royal Free Hampstead NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 14/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul D Griffiths
Scientific

Department of Virology
The Royal Free & University Medical School
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Phone	+44 (0)20 7830 2997 ext 4951
Email	p.griffiths@medsch.ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Open-label randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Determining a viral load threshold for pre-emptive therapy for cytomegalovirus infection in transplant patients using real time PCR monitoring
Study objectives	The aim of this study is to determine if quantitative measures of CMV viraemia can be applied to improve the treatment of CMV infection, and to evaluate the threshold of CMV viral load for initiation or discontinuation of pre-emptive therapy.
Ethics approval(s)	Research Ethics Committee (REC), 20/11/2002, ref: 6077, re-approved on the 16th November following an MHRA audit
Health condition(s) or problem(s) studied	Cytomegalovirus (CMV) infection
Intervention	Group A: 72 patients with low level CMV reactivation Group B: 106 patients receiving pre-emptive therapy
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	178
Key inclusion criteria	178 patients in total: stem cell, renal and liver transplant recipients with CMV reactivation
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	05/12/2002
Date of final enrolment	01/04/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Royal Free & University Medical School

London
NW3 2QG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/09/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/02/2020: ClinicalTrials.gov number added.
18/04/2017: Publication reference added.
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.