Trial of Aciclovir Prophylaxis of Herpes Infections in Critical Care - TRAPHICC

Phase 1

• Conditions: Herpes simplex virus infection - prophylaxis in critically ill patients on ventilators

• Registration Number: EUCTR2006-000612-24-GB
• Lead Sponsor: Greater Glasgow Health Board (North Glasgow University Hospitals Division)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

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

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.

Study & Design

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