PREVAIL study - PREVenting infection using Antimicrobial Impregnated Long lines

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81931394

Enrollment

858

Registered

2014-11-21

Start date

2015-06-01

Completion date

Unknown

Last updated

2019-05-27

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

Conditions

Infectious disease, preterm babies requiring a PICC Neonatal Diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026