Anti-viral medication to prevent the reactivation of the cytomegalovirus infection in critical care patients

Phase 1

• Conditions: reactivation of cytomegalovirus infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024646-30-GB
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-24
• Study Completion: 2017-01-19
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Total hospital stay of less than 7 days •This study aims to assess prophylaxis to prevent CMV reactivation. Patients screened for inclusion will include those hospitalised for less than 7 days prior to admission to intensive care in order to minimise the inclusion of patients admitted late on in their disease process, with pre-existing critical illness CMV reactivation. Inpatients deemed medically fit in the 7 days prior to ICU admission, eg rehab wards will be accepted for study inclusion CMV seropositive •Patients testing CMV positive only will be approached for inclusion in the interventional arm of the study. Patients testing CMV negative will enter the observational arm of the study, and no patient identifiers will be retained. ICU stay of >48 hours •Patient recruitment will be deferred until the end of a 24hr period on the ICU. This period is essential in order to develop a rapport with the patient and family as part of the consent process, to obtain results of CMV status assays, and to make an assessment regarding suitability of the patient for inclusion in the study. Mechanically ventilated, anticipated to continue for > 48 hours •In order to minimise the numbers of patients receiving therapy unnecessarily, and maximise the likelihood of identifying a clinical effect, the study group selects patients with higher risk of reactivation based on previous publications.
Are the trial subjects under 18? no
Number of subjects for this age range: 141
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Age <18 years Pregnancy or breast feeding Expected to survive < 48hrs Confirmed immunosuppression •Known or suspected Human Immunodeficiency Virus infection •Known or suspected underlying immunodeficiency (organ transplant, congenital immunodeficiency, in receipt of immunosuppressive medication e.g. azathioprine, tacrolimus, cyclosporine, sirolimus, cyclophosphamide within 30 days, steroids allowed up to 10mg prednisolone/day on average over 30 days, or stress dose hydrocortisone at up to 400mg/day, short doses of steroids allowed for up to 10 days. •Receipt of chemotherapeutic agent within the last 6 months Severe neutropenia (neutophil count <1000/mm3) Use of systemic antiviral medication within the last 7 days Allergy to study drugs Isolated brain injury

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified