PREVAIL Version 1.0
Research type
Research Study
Full title
PREVenting infection using Antimicrobial Impregnated Long lines. An unblinded, 2-arm randomised controlled trial to determine the effectiveness of antimicrobial impregnated (with rifampicin and miconazole) long lines (termed peripherally inserted central catheters, or AM- PICC (AM-PICC)) compared with standard PICC (S-PICC) for reducing blood stream infection (BSI).
IRAS ID
160376
Contact name
Ruth Gilbert
Contact email
Sponsor organisation
Great Ormond Street Hospital
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Many babies who are admitted to neonatal units need fluids and medicines given to them through their veins. These are often given through a peripherally inserted central catheter (PICC). A PICC is a very narrow tube placed through the skin of the arm/leg and into a central vein. These PICCs can stay in place for several weeks, avoiding the need for repeated venepunctures (putting a needle into a vein). However, very occasionally these PICCs can cause infections in the blood.
There are currently two types of licensed PICCs available:
• Standard (no coating and currently used by hospitals).
• Antimicrobial (antibiotic and antifungal coated - This coating might prevent infection by killing bacteria/fungi).The NIHR funded CATCH trial (ISRCTN: 34884569) is currently investigating antibiotic catheters in children, however, we need to find out which catheter (PICC) is better in very preterm babies, who require extremely narrow catheters and are much more susceptible to infection. Impregnated narrow catheters have never before been evaluated in clinical trials. The only way to know for certain is to compare babies who are given an antimicrobial PICC with those who are given a standard PICC in a clinical trial. Because we do not know which type of PICC is best, the type of PICC each child receives in the study will be decided randomly by chance. Each child will have the same chance of getting either PICC.
The aim of this study is to see how the two types of PICCs compare in reducing the risk of blood infections in babies the costs involved. We hope to recruit 858 babies over 2 years from 18 neonatal units in England. The information we gather from this study will guide policy about purchasing coated versus non-coated PICCs across the NHS and thereby improve treatment for babies in the future.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1202
Date of REC Opinion
31 Oct 2014
REC opinion
Further Information Favourable Opinion