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

Phase 3

Completed

• Conditions: ewly diagnosed hydrocephalus; Nervous System Diseases; Hydrocephalus

• Registration Number: ISRCTN49474281
• Lead Sponsor: Alder Hey Children's Hospital Foundation Trust (UK)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24383496 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31522843 results (added 17/09/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32238262 results (added 03/04/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36303476/ Post hoc analysis (added 06/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-17
• Study Completion: 2013-08-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1605

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified