CATCH - Catheter Infections in Children

February 15, 2022 updated by: Institute of Child Health

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1859

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 1EH
        • Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weighing ≥3kg and less than 16 years of age;
  • Admitted to or being prepared for admission to an intensive care unit participating in the trial;
  • Require insertion of a polyurethane CVC as part of good clinical management;
  • Require one of the CVC sizes available to the trial (see Appendix A for the list of CVCs);
  • Expected to require a CVC for at least 3 days;
  • Appropriate consent obtained (prospective consent for elective surgical patients, deferred consent for emergency admission patients).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard polyurethane Central Venous Catheter

Standard polyurethane Central Venous Catheter

All CVCs used in the trial are CE marked medical devices used for their intended purpose.
Device: Standard polyurethane Central Venous Catheter
Standard polyurethane Central Venous Catheter, All CVCs used in the trial are CE marked medical devices used for their intended purpose.
Active Comparator: Antibiotic impregnated polyurethane CVC

Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)

All CVCs used in the trial are CE marked medical devices used for their intended purpose.
Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
Antibiotic impregnated polyurethane CVC (minocycline and rifampicin. All CVCs used in the trial are CE marked medical devices used for their intended purpose.
Active Comparator: Heparin bonded polyurethane CVC

Heparin bonded polyurethane CVC

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be time to first blood stream infection defined by a positive blood culture from a sample that was clinically indicated and taken more than 48 hours after CVC insertion and up to 48 hours after CVC removal.
Time Frame: 48 HOURS
48 HOURS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Child Health

Investigators

  • Study Director: Ruth Gilbert, Professor, Institute of Child Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (Estimate)

December 10, 2009

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08EB20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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