Condition category
Nervous System Diseases
Date applied
11/12/2012
Date assigned
17/12/2012
Last edited
09/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Two new devices have been introduced to try to reduce shunt infection; Bactiseal and Silverline shunts. This study will compare these new shunts to standard shunts. Our goal is to establish which provides most protection against infection and to ensure standardisation of care.

Who can participate?
Children and adults with newly diagnosed hydrocephalus.

What does the study involve?
Patients will be randomly chosen to receive either standard, Bactiseal or Silverline shunts. The patient will have a follow up every three months via the telephone and a questionnaire by post.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to future patients requiring this treatment as they will potentially have reduced shunt infection.
The main risk of infection is complications for the patients which can leads to prolonged hospital stay, multiple operations and reduced IQ.

Where is the study run from?
Alder Hey Children’s Hospital NHS Foundation Trust.

When is study starting and how long is it expected to run for?
Recruitment will start in early 2013, for 2 years. Patients will be followed up for a maximum of 2.5 years.

Who is funding the study?
National Institute of Health Research – Health Technology Assessment Programme

Who is the main contact?
Mr Tom Kearns
thomas.kearns@liv.ac.uk

Trial website

http://www.basicsstudy.org.uk/

Contact information

Type

Scientific

Primary contact

Mr Conor Mallucci

ORCID ID

Contact details

Alder Hey Childrens NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2.0

Study information

Scientific title

National three-arm, double blind multi-centre randomised controlled trial comparing Bactiseal (antibiotic-impregnated), Silverline (silver-impregnated) and standard (non-impregnated) VPS in patients with newly diagnosed hydrocephalus undergoing insertion of their first permanent shunt.

Acronym

BASICS

Study hypothesis

Shunt failure due to infection has plagued this neurosurgical advance ever since it was developed. The incidence of shunt infection varies markedly in the literature from 3-27% (2-6) and is higher in certain groups, e.g. neonates and children under 1 year old, patients treated with a previous temporary external ventricular drain (EVD). Episodes of shunt infection have a significant impact on patients and the NHS and require prolonged inpatient hospitalisation, additional surgery to remove the infected hardware, placement of a temporary EVD, intravenous and intrathecal antibiotics, and further surgery to place a new shunt once the infection has been treated. Other clinical consequences of infection including epilepsy, reduced IQ and loculation have often been reported but never formally studied in the context of a prospective clinical trial. This trial thus addresses the primary question of which shunt catheter is most effective in reducing shunt infection and also has secondary questions addressing the consequences of infection in a clinical and financial context.

More details can be found here: http://www.hta.ac.uk/project/2902.asp

Ethics approval

Not provided at time of registration

Study design

Three-arm, multi-centre phase III randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Newly diagnosed hydrocephalus

Intervention

We will randomly allocate patients to a standard non impregnated ventriculoperitoneal shunt (VPS), a
Silverline (Silver impregnated) VPS or a Bactiseal (antiobiotic impregnated) VPS on a ratio of 1:1:1. All VPS
used for the trial are CE marked medical devices being used for their intended purpose.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

To determine whether antibiotic or silver impregnated ventriculoperitoneal shunt (VPS) reduce early infection (within 6 months) compared to standard VPS in newly diagnosed hydrocephalus following insertion of the first de novo VPS

Secondary outcome measures

1. To determine the proportion of delayed VPS infections (occurring > 6 months following de novo insertion)
2. To determine which organisms and their resistance / sensitivities, subsequently infect these three alternative VPS
3. To assess the clinical impact of each VPS infection
4. To determine the infection rate following the first (non-infected) clean VPS revision for mechanical failure
5. To assess the cost-effectiveness and health economics of antibiotic and silver impregnated VPS compared to standard VPS
6. To improve the diagnostics of suspected shunt infections through molecular diagnostic approaches

Overall trial start date

01/03/2013

Overall trial end date

01/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed hydrocephalus of any aetiology (including idiopathic intracranial hypertension)
2. VPS is the primary treatment option
3. Clear CSF sample at the time of shunt insertion
3.1. Failed primary endosopic third ventriculostomy allowed
3.2. Previous indwelling ventricular access device (e.g. Ommaya or Rickham reservoir or similar) allowed
3.3. Previous indwelling EVD allowed

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

Participant exclusion criteria

1. Previous indwelling VPS
2. Active and on-going CSF or peritoneal infection
3. Multi-loculated hydrocephalus requiring multiple VPS or neuro-endoscopy
4. Ventriculo-atrial or ventriculo-pleural shunt planned
5. Allergy to antibiotics associated with the antibiotic shunt

Recruitment start date

01/03/2013

Recruitment end date

01/08/2013

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Alder Hey Childrens NHS Foundation Trust
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

Alder Hey Children's Hospital Foundation Trust (UK)

Sponsor details

Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5673
Katherine.jopson@alderhey.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.alderhey.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/104/30

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24383496

Publication citations

  1. Protocol

    Jenkinson MD, Gamble C, Hartley JC, Hickey H, Hughes D, Blundell M, Griffiths MJ, Solomon T, Mallucci CL, The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol., Trials, 2014, 15, 4, doi: 10.1186/1745-6215-15-4.

Additional files

Editorial Notes