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

Phase 1

• Conditions: Transplant recipients with CMV infection.

• Registration Number: EUCTR2007-003472-19-GB
• Lead Sponsor: Royal Free Hampstead NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 178

Inclusion Criteria

1. All Stem Cell, Renal and Liver Transplant recipients
2. Wiling to give informed consent
3. A) All patients with CMV viraemia (between 200 and 3000 copies/ml) in the liver, renal and stem cell groups in two consecutive samples.
B) Those patients requiring pre-emptive therapy because viral load is > 3,000 copies/ml
4. All patients in either section of the study must be available for CMV PCR monitoring at least twice per week.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Profound neutropaenia considered to preclude administration of ganciclovir or profound renal failure considered to preclude administration of foscarnet
2. Inability to give informed consent
3. In the stem cell group, Donor negative, Recipient negative transplants.
4. In the stem cell group: matched unrelated donors who are CMV seronegative
5. Those patients who have been in Group A cannot then enter the Group B part of the study.
6. Those patients who have been in Group B cannot then enter the Group A part of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: 1. To define 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<br> 2 To define 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.<br> ;<br> Secondary Objective: To define the duration of antiviral therapy needed to treat CMV viraemia<br> 2. To record the rate of increase in viral load prior to starting preemptive therapy<br> 3. To correlate viral loads with CMV specific immune function<br> ;Primary end point(s): The number of patients in whom viral load increases above 3,000 copies/ml