Catheter-related InfectionsPhase 3NCT01029717
CATCH - Catheter Infections in Children
A Phase 3 study testing Standard polyurethane Central Venous Catheter, Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) and Heparin bonded polyurethane CVC in people with Catheter-related Infections, run by Institute of Child Health at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Catheter-related Infections
- What is being tested?
- Standard polyurethane Central Venous Catheter, Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) and Heparin bonded polyurethane CVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,859 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Catheter-related Infections
- Being tested
- Standard polyurethane Central Venous Catheter, Antibiotic impregnated polyurethane CVC (minocycline and rifampicin), Heparin bonded polyurethane CVC
- Keywords
- Central Venous Catheters, blood stream infection, children, intensive care, Heparin bonded, antibiotic coated, Children in Paediatric Intensive Care Unit
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard polyurethane Central Venous Catheter | Experimental | Standard polyurethane Central Venous Catheter
All CVCs used in the trial are CE marked medical devices used for their intended purpose. Receives: Device: Standard polyurethane Central Venous Catheter |
| Antibiotic impregnated polyurethane CVC | Active comparator | Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
All CVCs used in the trial are CE marked medical devices used for their intended purpose. Receives: Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) |
| Heparin bonded polyurethane CVC | Active comparator | Heparin bonded polyurethane CVC
All CVCs used in the trial are CE marked medical devices used for their intended purpose. Receives: Device: Heparin bonded polyurethane CVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startDec 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catheter-related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Gilbert, Professor, Study director, Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029717
- Sponsor's protocol ID
- 08EB20
- Status last verified
- Feb 2022
- First submitted
- 9 Dec 2009
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Pierce CM, Wade A, Mok Q. Heparin-bonded central venous lines reduce thrombotic and infective complications in critically ill children. Intensive Care Med. 2000 Jul;26(7):967-72. doi: 10.1007/s001340051289.
PubMed 10990114Harron K, Mok Q, Dwan K, Ridyard CH, Moitt T, Millar M, Ramnarayan P, Tibby SM, Muller-Pebody B, Hughes DA, Gamble C, Gilbert RE. CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children. Health Technol Assess. 2016 Mar;20(18):vii-xxviii, 1-219. doi: 10.3310/hta20180.
PubMed 26935961Harron K, Woolfall K, Dwan K, Gamble C, Mok Q, Ramnarayan P, Gilbert R. Deferred Consent for Randomized Controlled Trials in Emergency Care Settings. Pediatrics. 2015 Nov;136(5):e1316-22. doi: 10.1542/peds.2015-0512. Epub 2015 Oct 5.
PubMed 26438711
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01029717
- Acronym / sponsor ID
- 08EB20
- Conditions
- Catheter-related Infections
- Keywords
- Central Venous Catheters, blood stream infection, children, intensive care, Heparin bonded, antibiotic coated, Children in Paediatric Intensive Care Unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,859 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard polyurethane Central Venous Catheter | Experimental | Device: Standard polyurethane Central Venous CatheterStandard polyurethane Central Venous Catheter All CVCs used in the trial are CE marked medical devices used for their intended purpose. |
| Antibiotic impregnated polyurethane CVC | Active comparator | 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. |
| Heparin bonded polyurethane CVC | Active comparator | Device: Heparin bonded polyurethane CVCHeparin bonded polyurethane CVC All CVCs used in the trial are CE marked medical devices used for their intended purpose. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard polyurethane Central Venous CatheterStandard 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 |
| 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. | Device | Antibiotic impregnated polyurethane CVC |
| Heparin bonded polyurethane CVCHeparin bonded polyurethane CVC. All CVCs used in the trial are CE marked medical devices used for their intended purpose. | Device | Heparin bonded polyurethane CVC |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Background: PubMed 10990114Pierce CM, Wade A, Mok Q. Heparin-bonded central venous lines reduce thrombotic and infective complications in critically ill children. Intensive Care Med. 2000 Jul;26(7):967-72. doi: 10.1007/s001340051289.
- Results publication: PubMed 26935961Harron K, Mok Q, Dwan K, Ridyard CH, Moitt T, Millar M, Ramnarayan P, Tibby SM, Muller-Pebody B, Hughes DA, Gamble C, Gilbert RE. CATheter Infections in CHildren (CATCH): a randomised controlled trial and economic evaluation comparing impregnated and standard central venous catheters in children. Health Technol Assess. 2016 Mar;20(18):vii-xxviii, 1-219. doi: 10.3310/hta20180.
- Derived from this study: PubMed 26438711Harron K, Woolfall K, Dwan K, Gamble C, Mok Q, Ramnarayan P, Gilbert R. Deferred Consent for Randomized Controlled Trials in Emergency Care Settings. Pediatrics. 2015 Nov;136(5):e1316-22. doi: 10.1542/peds.2015-0512. Epub 2015 Oct 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Gilbert, Professor study director
Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard polyurethane Central Venous Catheter, Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) and Heparin bonded polyurethane CVC in people with Catheter-related Infections, run by Institute of Child Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029717, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.