CATCH - Catheter Infections in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Institute of Child Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT01029717
First received: December 9, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Catheter-Related Infections
Device: Standard polyurethane Central Venous Catheter
Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
Device: Heparin bonded polyurethane CVC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: January 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029717

Contacts
Contact: Tracy Ball +44 (0)20 74058207

Locations
United Kingdom
Institute of Child Health Not yet recruiting
London, United Kingdom, WC1N 1EH
Contact: TRACY BALL    +44 (0)20 74058207      
Principal Investigator: QUEN MOK, DR         
Sponsors and Collaborators
Institute of Child Health
Investigators
Study Director: Ruth Gilbert, Professor Institute of Child Health
  More Information

Publications:
Responsible Party: RESEARCH AND DEVELOPMENT OFFICE, INSTITUTE OF CHILD HEALTH
ClinicalTrials.gov Identifier: NCT01029717     History of Changes
Other Study ID Numbers: 08EB20
Study First Received: December 9, 2009
Last Updated: December 9, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:
Central Venous Catheters
blood stream infection
children, intensive care
Heparin bonded
antibiotic coated
Children in Paediatric Intensive Care Unit

Additional relevant MeSH terms:
Catheter-Related Infections
Communicable Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcium heparin
Heparin
Minocycline
Rifampin
Anti-Infective Agents
Anticoagulants
Antitubercular Agents
Cardiovascular Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014