Antiviral Prophylaxis to Prevent Cytomegalovirus Reactivation in ITU

• Research type

  Research Study

• Full title

  Anti-viral prophylaxis for prevention of cytomegalovirus (CMV) reactivation in immunocompetent patients in critical care.

• IRAS ID

  63682

• Contact name

  Julian Bion

• Sponsor organisation

  University Hospitals Birmingham NHS Foundation Trust

• Eudract number

  2010-024646-30

• ISRCTN Number

  isrctn

• Research summary

  Cytomegalovirus (CMV) is a common virus which infects a large proportion of the population. Around half the UK population will have been infected by adulthood. Infection is usually mild in healthy people, but after infection the virus is never completely eradicated, and may reactivate in ill health. Reactivation is most commonly seen in those with compromised immune systems, such as people with advanced HIV infection, or whilst on immunosuppression following organ transplantation. CMV reactivation in these patients can be life threatening. There is good evidence to support the use of antiviral medication in these groups of immunosuppressed patients to prevent CMV reactivation, and indeed there are drugs licenced for this purpose in specific groups and their use is part of standard therapy. Recently, an increasing body of evidence has accumulated demonstrating that around a third of critically ill patients will reactivate latent CMV. Being critically ill is associated with a reduced capacity to fight infection. Several research groups have demonstrated that mortality is much higher, and as much as doubled, in patients that reactivate CMV in critical care. Antiviral prophylaxis is currently not standard practice in intensive care. Experts in the field believe that a trial is required to identify whether these patients would have improved outcomes if CMV reactivation was prevented using anti-viral prophylaxis. We have designed a study in which critically ill patients with previous CMV infection are entered into a three armed study. Patients would either be treated with valaciclovir, valganciclovir or with no prophylaxis. This feasibility study is designed to demonstrate drug efficacy and tolerability using a strategy to minimise drug side effects in this group of patients. We intend to use data and methodology from this feasibility study to set up a large multicentre trial powered to identify clinical endpoints including 28 day mortality.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/H0709/10

• Date of REC Opinion

  22 Mar 2011

• REC opinion

  Further Information Favourable Opinion