Trial of aciclovir in the prophylaxis of herpes infections in critical care
ISRCTN | ISRCTN29934637 |
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DOI | https://doi.org/10.1186/ISRCTN29934637 |
EudraCT/CTIS number | 2006-000612-24 |
Secondary identifying numbers | WN06AN002 |
- Submission date
- 13/02/2006
- Registration date
- 14/03/2006
- Last edited
- 19/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alexander Binning
Scientific
Scientific
Intensive Therapy Unit
Western Infirmary
Glasgow
G11 5JR
United Kingdom
Study information
Study design | Double-blind, randomised, parallel group placebo-controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Scientific title | Trial of aciclovir in the prophylaxis of herpes infections in critical care |
Study acronym | TRAPHICC |
Study objectives | 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(s) | 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). |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2006 |
Completion date | 30/09/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 500 |
Key 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 |
Key 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 |
Date of first enrolment | 01/06/2006 |
Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Intensive Therapy Unit
Glasgow
G11 5JR
United Kingdom
G11 5JR
United Kingdom
Sponsor information
Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)
Hospital/treatment centre
Hospital/treatment centre
Room 9
Administration Building
Western Infirmary
Glasgow
G11 6NT
Scotland
United Kingdom
Phone | +44 (0)141 211 1817 |
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judith.godden@northglasgow.scot.nhs.uk | |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZB/4/375)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Basic results | 04/02/2021 | 19/05/2022 | No | No |
Editorial Notes
19/05/2022: EU Clinical Trials Register results added.
26/08/2016: No publications found, verifying study status with principal investigator