Condition category
Neonatal Diseases
Date applied
13/11/2014
Date assigned
21/11/2014
Last edited
21/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A peripherally inserted central catheter (PICC) is a long, thin tube that goes into a vein in the upper arm. Babies in neonatal units often need to take medicines and fluids through PICCs for a long time. PICCs are inserted in order to avoid the need for repeated painful procedures and can stay in place for several weeks. However, very occasionally these PICCs can cause infections in the blood. There are currently two types of PICCs available. One type is coated with an antibiotic and an antifungal which might prevent infection by killing bacteria (AM-PICC), and the other type is not (a standard PICC). Although both are available, currently hospitals tend to use the standard PICC (S-PICC). We are currently investigating antimicrobial catheters in children, however, we also need to find out which catheter (PICC) is better in babies or if there is no difference between them. The study will help hospitals to decide which type of PICC to use for babies admitted to neonatal intensive care in the future.

Who can participate?
Babies who require the narrowest PICC.

What does the study involve?
Participating babies will be randomly allocated to be treated with either an AM-PICC or a S-PICC. The study will follow your baby using routine records and will use infection results from samples that need to be taken as part of your baby's routine clinical care. When your baby's PICC is removed, we will also test the tip for bacteria. Information will also be collected from the babies' hospital admission up till 6 months after they have entered the study.

What are the possible benefits and risks of participating?
Both PICCs are CE marked for use in babies which means they comply with EU legislation. Currently normal practise in hospitals is to use the standard PICCs; however, there is no evidence to support that these are better or worse than AM-PICC. For all PICCs there is a small risk that they may become infected and cause an infection in the blood. By using the antimicrobial PICCs this risk of infection may decrease. As the antimicrobial PICCs do contain a tiny amount of antibiotic and antifungal, there is a potential that instead of being beneficial they could be problematic. However, the main foreseeable disadvantage, that bacteria/fungi might become resistant to the antibiotic/antifungal, is very unlikely indeed to have any impact on a baby's care.

Where is the study run from?
The study will be run from 18 neonatal units in the UK. The lead centre will be Bradford Teaching Hospitals NHS Foundation Trust. The study will be co-ordinated through the Medicines for Children Clinical Trials Unit, University of Liverpool.

When is the study starting and how long is it expected to run for?
The study will run from December 2014 until August 2017.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Professor Ruth Gilbert and Dr Sam Oddie
prevail@liverpool.ac.uk

Trial website

http://prevailtrial.org.uk/

Contact information

Type

Scientific

Primary contact

Prof Ruth Gilbert

ORCID ID

Contact details

MRC Centre of Epidemiology for Child Health
UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
-
r.gilbert@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 12/167/02; 12EB13

Study information

Scientific title

An unblinded, two-arm randomised controlled trial to determine the effectiveness and cost-effectiveness of antimicrobial impregnated (with rifampicin and miconazole) long lines (termed peripherally inserted central venous catheters, or AM-PICC) compared with standard PICC (S-PICC) for reducing blood stream infection (BSI)

Acronym

PREVAIL

Study hypothesis

The overall aim of the study is to determine whether AM-PICC should be introduced across the NHS for preterm babies. In very preterm infants, does the use of antimicrobial impregnated PICC, compared to standard PICC, reduce blood stream infection and is it cost effective?

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1216702

Ethics approval

NRES Committee -Yorkshire & The Humber - Sheffield, 31/10/2014, Ref: 14/YH/1202

Study design

Unblinded two-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Infectious disease, preterm babies requiring a PICC

Intervention

1. Antimicrobial impregnated (with rifampicin and miconazole) peripherally inserted central venous catheters (AM-PICC)
2. Standard PICC (S-PICC)

Intervention type

Device

Phase

Drug names

Primary outcome measures

Time to first blood stream infection based on a positive blood culture (including fungal BSI) taken between 24 hours after randomisation until 48 hours after removal.

As part of the primary endpoint there will be two sensitivity analyses:
1. A sensitivity analysis confined to clinically serious BSI defined by positive culture and the baby is treated for more than 72 hours with intravenous antibiotics or dies during treatment
2. Time to first BSI based on a positive blood culture (including fungal BSI) taken between 24 hours after PICC insertion until 48 hours after removal

Secondary outcome measures

1. Rifampicin or miconazole resistance in any isolate from blood culture
2. Rifampicin or miconazole resistance in any isolate from PICC tips
3. Death within 6 months of randomisation
4. Death before discharge
5. Rate of BSI per 1000 PICC-days (including recurrent BSI)
6. Rate of one or more BSI
7. Rate of catheter-related BSI
8. Time to a composite measure of BSI including culture-negative BSI (based on reason for antibiotic treatment beyond 72 hours after a negative blood culture sample)
9. Rate of blood culture sampling per 1000 PICC days
10. Duration of antimicrobial exposure from randomisation up to 48 hours after line removal
11. Rate of chronic lung disease 36 weeks postmenstrual age
12. Rate of necrotizing enterocolitis (NEC): Bell’s stage II or III
13. Rate for treatment for retinopathy of prematurity before NNU discharge
14. Rate of abnormalities on cranial ultrasound
15. Time to full milk feeds after randomisation
16. Breast milk intake at discharge from NNU
17. Total duration of parenteral nutrition from randomisation until discharge from NNU
18. Time to PICC removal

Overall trial start date

01/12/2014

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Babies who require a PICC (Premicath 1 Fr)
2. Admitted to a NNU that is recruiting for this trial
3. Parent/legal representative of the baby gives informed written consent for the trial

Note: Babies with the following can be included in the trial:
1. Congenital malformations
2. Gastrointestinal surgical conditions
3. Previous PICC (non-trial PICC)
4. Previously treated BSI which has resolved in the opinion of the Investigator

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

858

Participant exclusion criteria

1. Baby has been previously entered into this trial
2. Baby has a known allergy or hypersensitivity to rifampicin or miconazole

Recruitment start date

01/06/2015

Recruitment end date

31/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Homerton Hospital
London
E9 6SR
United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Trial participating centre

Newham University Hospital
Plaistow
E13 8SL
United Kingdom

Trial participating centre

Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Nottingham University Hospital (QMC)
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Queen's Hospital
Romford
RM7 0AG
United Kingdom

Trial participating centre

Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Royal Oldham Hospital
Oldham
OL1 2JH
United Kingdom

Trial participating centre

Royal Preston Hospital
Preston
PR2 9HT
United Kingdom

Trial participating centre

St Mary's Hospital
Manchester
M13 0JH
United Kingdom

Trial participating centre

St Michael's Hospital
Bristol
BS2 8EG
United Kingdom

Trial participating centre

The Jessop Wing
Sheffield
S10 2SF
United Kingdom

Trial participating centre

The Royal London Hospital
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Great Ormond Street Hospital for Children NHS Foundation Trust (UK)

Sponsor details

c/o Emma Pendleton
Joint Research & Development Office
Division of Research & Innovation
Great Ormond Street Hospital for Children NHS Foundation Trust
UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0) 207 905 2271
RandDgovernance@gosh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes