Additional identifiers
EudraCT number
2006-000612-24
ClinicalTrials.gov number
Protocol/serial number
WN06AN002
Study information
Scientific title
Trial of aciclovir in the prophylaxis of herpes infections in critical care
Acronym
TRAPHICC
Study hypothesis
The overall aim of this proof of concept study is to serve as a pilot study for a multicentre study powered to detect improvement in Intensive Care Unit (ICU) mortality by giving aciclovir prophylaxis to prevent Herpes Simplex Virus (HSV) infection in the lungs.
As of 01/06/2009 this record has been updated to include an extension to the anticipated end date; the initial end date at the time of registration was 31/05/2008.
Ethics approval
Multi-Centre Research Ethics Committee for Scotland (Committee A) approved on the 28/03/2008 (ref: 06/MRE00/14; Protocol Number: 3; EudraCT Number: 2006-000612-24).
Study design
Double-blind, randomised, parallel group placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Herpes simplex virus infection of the lower respiratory tract in critically ill patients
Intervention
Administration of 15 mg/kg per day aciclovir or placebo by infusion three times daily over 1 hour
Intervention type
Drug
Phase
Not Specified
Drug names
Aciclovir
Primary outcome measure
The primary endpoint is the mean change in Karnofsky index from baseline to day 28 +/- 2 days and 90 +/- 2 days after entry to the study
Secondary outcome measures
1. Proportion of patients with HSV detected during ICU stay in lower respiratory secretions; proportion of patients with HSV detected during ICU stay in blood samples
2. In patients in whom HSV is detected during ICU stay, proportions of infections due to primary infection and reactivation of latent infection
3. At each sampling time point, the correlation between HSV lymphocyte response and viral titres
4. Mean plasma soluble cytokine levels in patients with and without HSV infection; mean respiratory secretion soluble cytokine levels in patients with and without HSV infection
5. Proportions of patients with HSV reactivation according to type of cytokine response
6. Mean complement activation before HSV is detected, after HSV detection and in patients where HSV is not detected during ICU stay
7. Proportion of patients in whom each of Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Human Herpes Virus Six (HHV6) and Human Herpes Virus Seven (HHV7) infections are detected during ICU stay
8. Median number of days on ventilation, median ICU stay, frequency of prescription of each of anti-retroviral agents, corticosteroids, immunosuppressive agents
9. Proportion of patients surviving at 90 days following ICU admission
10. Number of days of survival following ICU admission
11. The survival time for patients surviving beyond 90 days will be censored at 90 days
12. Proportion of HSV infections which are HSV1, proportion of HSV infections which are HSV2
13. Mean vital signs, white cell count and creatinine clearance during ICU stay
14. Reporting of adverse events occurring during randomised treatment or during the 7 days following the end of randomised treatment
Overall trial start date
01/06/2006
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients 18 years or over entering ICU
2. Patient expected to stay in the ICU longer than 36 hours and intubated with an endotracheal or tracheostomy tube within 24 hours of admission to ICU
3. Patient not requiring treatment with aciclovir, valaciclovir, ganciclovir, foscarnet, probenicid or other drug known to have anti-herpes simplex activity
4. Patient must have no known allergy to aciclovir
5. Females of childbearing age must have negative pregnancy test on admission
6. Written informed consent from the patient or assent obtained from relatives
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Duration of admission confidently expected to be less than 36 hours
2. Patients with endotracheal or tracheostomy tube placed more than 24 hours before admission to ICU
3. Patient has clinical features of HSV disease
4. Patient previously randomised to this study
5. Patients deemed to be suitable for entry to another trial
6. Previous hypersensitivity to aciclovir or valaciclovir
7. Patient requiring agent with anti-herpes virus activity
8. Patient previously enrolled in another trial of an investigational drug within the past 30 days
9. Patient is pregnant or lactating
Recruitment start date
01/06/2006
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Intensive Therapy Unit
Glasgow
G11 5JR
United Kingdom
Sponsor information
Organisation
Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)
Sponsor details
Room 9
Administration Building
Western Infirmary
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 1817
judith.godden@northglasgow.scot.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZB/4/375)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list