Cytomegalovirus Control in Critical Care

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether reactivation of latent cytomegalovirus infection in critically ill patients looked after in the intensive care unit can be successfully and safely prevented using antiviral agents. Comparison is made between standard care, and treatment with one of two different antiviral regimens: valaciclovir/aciclovir, which has a favourable side effect profile but requires high dosage to be effective, and valganciclovir/ganciclovir, which has more side effects, but has been demonstrated to be effective in low dosage.

The primary hypothesis is that cytomegalovirus reactivation can be effectively suppressed with antiviral prophylaxis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Acyclovir; Ganciclovir; Ganciclovir triphosphate; Valacyclovir; Valganciclovir

Criteria

Inclusion Criteria:

• Total hospital stay of less than 7 days

• CMV seropositive

• Critical care stay of >24 hours

• Mechanically ventilated, anticipated to continue for > 48 hours

Exclusion Criteria:

• Known Pregnancy or breast feeding

• Expected to survive less than 48 hours

• Confirmed immunosuppression

• Known or suspected Human Immunodeficiency Virus infection

• Known or suspected underlying immunodeficiency (organ transplantation including stem cell transplantation on immunosuppression, congenital immunodeficiency, in receipt of immunosuppressive medication e.g. azathioprine, methotrexate, tacrolimus, cyclosporine, sirolimus, cyclophosphamide within 30 days)

• Corticosteroids: Prednisolone chronic administration may be used up to a dose of 10mg/day on average over the preceding 30 days, stress dose hydrocortisone (up to 400mg/day) may be used, topical steroids may be used, short duration of higher dose steroids for exacerbations of chronic obstructive pulmonary disease (COPD) up to 1mg/kg prednisolone or equivalent are permitted for up to 14 days

• Receipt of chemotherapeutic agent within the last 6 months

• Use of systemic antiviral medication other than oseltamivir within the last 7 days.

• Intubated and mechanically ventilated secondary to brain injury alone.