Herpes simplex virus infection - prophylaxis in critically ill patients on ventilators
Conditions
Interventions
Trade Name: Zovirax/ Aciclovir. Note: For the trial, a single preparation from a single manufacturer will be used on all trial sites. Negociations are ongoing with manufacturer's about drug supply at
Sponsors
Greater Glasgow Health Board (North Glasgow University Hospitals Division)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients (over 18 years) entering ICU provided 1. Patient expected to stay in the ICU longer than 36 hours and with an endotracheal or tracheostomy tube inserted within 24 hours of admission to the ICU. 2. Patient does not require treatment with Aciclovir, Valaciclovir, Ganciclovir, Foscarnet, Probenicid or other drug known to have anti herpes simplex activity 3. Patient does not have a known allergy to Aciclovir. 4. Females of childbearing age must have negative pregnancy test on admission 5. Written informed consent from the patient or assent obtained from relatives. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Duration of admission confidently expected to be less than 36 hours b) Patient has clinical features of HSV disease c) Patient previously randomised to this study. d) Patients deemed to be suitable for entry to another trial e) Previous hypersensitivity to aciclovir or Valaciclovir f) Patient requiring agent with anti herpes virus activity g) Patient previously enrolled in another trial of an investigational drug within the past 30 days h) Patient is pregnant or lactating j) Patient with endotracheal or tracheostomy in place for more than 24 hours before admission to ICU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of aciclovir prophylaxis on recovery of physical functional status, measured using the Karnofsky score before and after an episode of intensive care.; Secondary Objective: 1. To demonstrate whether HSV detection is reduced by giving prophylactic intravenous Aciclovir to patients in the ICU. 2. To determine whether HSV detection is primary or reactivation. 3. To determine whether HSV lymphocyte responses correlate with viral titres. 4. To establish whether cytokine levels in respiratory secretions and plasma alter in the presence of HSV infection. 5. To evaluate whether the cytokine response predicts HSV reactivation. 6. To determine whether complement activation alters in relation to HSV infections. 7. To determine whether prevention of HSV infection in ICU patients alters the detection of other herpes viruses. 8. To evaluate the effects of aciclovir prophylaxis on clinical management 9. To determine the effects of aciclovir prophylaxis on mortality. 10. To characterise any HSV infections as HSV1 or HSV2. 11. To evaluate the safety and tolerability of aciclovir prophylaxis in ICU patients. ; Primary end point(s): The primary endpoint is the mean change in Karnofsky index from baseline to day 28 +/- 2days and day 90 +/- 2days after entry to the study | — |
Countries
United Kingdom
Outcome results
None listed