E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Herpes simplex virus infection - prophylaxis in critically ill patients on ventilators |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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90 days after the last patient is admitted to the trial. (For guidance, in the Western Infirmary ICU, the longest ICU stay in 2005 was 74 days) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |