Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Mr Conor Mallucci


Contact details

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

Additional identifiers

EudraCT number 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.



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:

Ethics approval

Not provided at time of registration

Study design

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Newly diagnosed hydrocephalus


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



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Alder Hey Childrens NHS Foundation Trust
L12 2AP
United Kingdom

Sponsor information


Alder Hey Children's Hospital Foundation Trust (UK)

Sponsor details

Eaton Road
L12 2AP
United Kingdom
+44 (0)151 252 5673

Sponsor type

Hospital/treatment centre



Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:

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