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

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN03307563

Enrollment

178

Registered

2003-09-12

Start date

2002-12-05

Completion date

Unknown

Last updated

2020-03-03

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

Conditions

Cytomegalovirus (CMV) infection Infections and Infestations Cytomegaloviral disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

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