CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,859 enrolled
Drug / intervention
Standard polyurethane Central Venous Catheter +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01029717
NCT01029717Phase 3Completed

A Randomised Controlled Trial Comparing the Effectiveness of Heparin Bonded or Antibiotic Impregnated Central Venous Catheters (CVCs) With Standard CVCs for the Prevention of Hospital Acquired Blood Stream Infection in Children

Institute of Child Health·interventional·Posted Dec 10, 2009·Updated Mar 3, 2022

In Brief

A Phase 3 clinical trial evaluating Standard polyurethane Central Venous Catheter, Antibiotic impregnated polyurethane CVC (minocycline and rifampicin), and 1 other intervention for Catheter-related Infections. Completed, enrolled 1,859 participants across 1 site.

Detailed Summary

Most children admitted to paediatric intensive care units (PICU) need to have medicines given to them into their veins using a narrow tube, so they do not need repeated injections. This tube is called a central venous catheter. Occasionally these catheters can cause infections in the blood and sometimes the tubes can get blocked by small blood clots. Some intensive care units already use antibiotic or heparin coated catheters, but there is no proof that these are better than the standard ones at preventing infections. Most of the PICU's in this country use standard lines. The only way to find out for certain is to compare children who are given antibiotic or heparin coated catheters with those who are given standard ones in a clinical trial. Because we do not know which type of catheter is best, the type of catheter each child receives in the study will be decided randomly by chance. Each child in the trial will have the same chance of getting any of these three catheters: * Standard central venous catheter (not coated). * Heparin coated central venous catheter. Heparin is a medicine that can stop blood from clotting and might stop the tubes being blocked and infections in the blood. * Antibiotic coated central venous catheter. Antibiotics can be used to kill bacteria which cause the infections. The aim of this study is to see how the three types of catheters compare in reducing the amount of blood infections in children. We will also look at the costs involved. We hope to recruit 1200 children in the UK over 2 years. We hope that the information we get from this study will guide policy about purchasing impregnated Central Venous Catheters across the NHS and thereby improve treatment for children in the future.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2009
Enrollment StartDec 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.6 years ago

Interventions

Standard polyurethane Central Venous Catheterdevice

Standard polyurethane Central Venous Catheter, All CVCs used in the trial are CE marked medical devices used for their intended purpose.

Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)device

Antibiotic impregnated polyurethane CVC (minocycline and rifampicin. All CVCs used in the trial are CE marked medical devices used for their intended purpose.

Heparin bonded polyurethane CVCdevice

Heparin bonded polyurethane CVC. All CVCs used in the trial are CE marked medical devices used for their intended purpose.