Status:
COMPLETED
Cytomegalovirus Control in Critical Care
Lead Sponsor:
University Hospital Birmingham NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pre...
Detailed Description
Background: \* Cytomegalovirus (CMV) is a common virus which infects around half the UK population. Infection is usually mild, but after infection the virus is never completely eradicated, and may re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01503918
Start Date
January 1 2012
End Date
March 1 2014
Last Update
January 12 2015
Active Locations (1)
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1
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2WB