Determining a viral load threshold for pre-emptive therapy for cytomegalovirus infection in transplant patients using real time PCR monitoring
ISRCTN | ISRCTN03307563 |
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DOI | https://doi.org/10.1186/ISRCTN03307563 |
ClinicalTrials.gov number | NCT00947141 |
Secondary identifying numbers | N0256119271 |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
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p.griffiths@medsch.ucl.ac.uk |
Study information
Study design | Open-label randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 05/12/2002 |
Completion date | 01/04/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
NW3 2QG
United Kingdom
Sponsor information
Hospital/treatment centre
Medical School Admin Offices
Room G649
Rowland Hill Street
London
NW3 2PF
England
United Kingdom
https://ror.org/01ge67z96 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 29/09/2016 | Yes | No |
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.