Cluster randomised trial of an intervention to promote implementation of clinical guidance on the management of suspected encephalitis

Not Applicable

Completed

• Conditions: Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations; Unspecified viral encephalitis

• Registration Number: ISRCTN06886935
• Lead Sponsor: niversity of Liverpool (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25623603 2015 results in: http://www.implementationscience.com/content/10/1/37 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30521521

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-22
• Study Completion: 2016-07-15
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1680

Inclusion Criteria

Site inclusion criteria:
All centres will have a consultant and all centres must be equipped with the ability to perform, or have access to CT/MRI scans and have aseptic conditions for conducting a LP to be performed. Hospitals will be randomised as a unit to either the standard care or intervention arm. Study centres will be initiated once all global (e.g. local research and development [R&D] approval) and study-specific conditions (e.g. training requirements) have been met, and all necessary documents have been returned to the Brain Infections UK coordinating centre.
Within this study, any patients who have suspected encephalitis within the recruited sites will be included in the study. The inclusion criteria for suspected encephalitis are:

Patients with suspected encephalitis
(a) Mandatory
Acute or sub-acute (<4 weeks) alteration in consciousness, cognition, personality or behaviour persisting for more than 24 hours. Personality/behaviour change includes: agitation, psychosis, somnolence, insomnia, catatonia, mood liability, altered sleep pattern and (in children): new onset enuresis, or irritability.
Plus ANY two of:
1. Fever (> 38ºC) / prodromal illness ? acute or sub-acute
2. Seizures: new onset
3. Focal neurological signs ? acute or sub-acute onset. These include:
3.1. Focal weakness
3.2. Oromotor dysfunction
3.3. Movement disorders (chorea, athetosis, dystonia, hemiballisms, stereotypies, orolingual dyskinesia and tics) including Parkinsonism (bradykinesia, tremor, rigidity and postural instability)
3.4. Amnesia
4. Pleocytosis: cerebrospinal fluid white cell count >4 cells/ul
5. Neuroimaging: compatible with encephalitis
6. Electroencephalogram (EEG): compatible with encephalitis
OR
(b) Clinical suspicion of encephalitis but above investigations have not yet been completed
OR
(c) Clinical suspicion of encephalitis and the patient died before investigations completed

Target Gender: Male & Female

Exclusion Criteria

Site exclusion criteria:
Current participation in the ENCEPH UK programme

Added 07/01/2015:
Patient exclusion criteria
Any patient aged under 28 days upon the date of admission shall be excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 07/01/2015:<br> The proportion of patients with suspected encephalitis whose care met all of the following criteria:<br> 1. Aciclovir given within 6 hours of admission to hospital<br> 2. A LP was performed within 12 hours of hospital arrival unless clinically contraindicated<br><br> Previous primary outcome measures:<br> The proportion of patients with suspected encephalitis whose care met all of the following criteria:<br> 1. Aciclovir given within 6 hours of admission to hospital at the appropriate dose unless there was an alternative diagnosis<br> 2. A LP was performed within 12 hours of hospital arrival unless clinically contraindicated.<br>