The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multi-centre randomised control trial

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49474281

Enrollment

1200

Registered

2012-12-17

Start date

2013-03-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed hydrocephalus Nervous System Diseases Hydrocephalus

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Early infection (within 6 months) following insertion of the first de novo VPS	—

Secondary

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

Measure

Time frame

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

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Countries

England, Ireland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026