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Critical Illness | Cytomegalovirus Control in Critical Care

Critical Illness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Valaciclovir/Aciclovir2g valaciclovir, four times a day, enterally for 28 days, or until discharge from the critical care unit, but for a minimum of 14 days unless discharged from hospital. Those unable to receive enteral drugs will receive intravenous aciclovir 10mg/kg three times a day. Dosing modified in the presence of renal dysfunction.

Drug:Valganciclovir/Ganciclovir450mg valganciclovir, once a day, by enteral route. Treatment will continue for 28 days, or until discharge from the critical care unit, but for a minimum of 14 days unless discharged from hospital. Intravenous ganciclovir 2.5mg/kg once a day will be used if drugs cannot be given enterally. Treatment dosing will be modified for renal dysfunction

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Valaciclovir/Aciclovir

Valganciclovir/Ganciclovir

control

Study Status

Completed

Start Date: January 2012

Completed Date: March 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Time to reactivation of cytomegalovirus (CMV) polymerase chain reaction (PCR) (defined as above the lower limit of sample assay).

Secondary Outcome: Time to reactivation above the lower limit of assay detection of CMV PCR in urine, throat swab and non-directed bronchiolar lavage (NDBL). NDBL whilst trachea is intubated only.

Study sponsors, principal investigator, and references

Principal Investigator: Julian F Bion, MD FRCP FRCA

Lead Sponsor: University Hospital Birmingham NHS Foundation Trust

Collaborator: National Institute for Health Research, United Kingdom

More information:https://clinicaltrials.gov/show/NCT01503918

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