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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003472-19-GB

Enrollment

178

Registered

2007-08-01

Start date

2007-09-13

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant recipients with CMV infection.

Interventions

Trade Name: Foscavir Product Name: foscarnet Pharmaceutical Form: Intravenous infusion Trade Name: Cymeve IV Product Name: Ganciclovir

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026