Condition category
Infections and Infestations
Date applied
25/11/2004
Date assigned
14/12/2004
Last edited
23/05/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Millar

ORCID ID

Contact details

Department of Microbiology
37 Ashfield Street
Whitechapel
London
E1 1BB
United Kingdom
+44 (0)20 73773078
M.R.millar@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 03/39/13; N0484156267

Study information

Scientific title

Acronym

MD-CVC

Study hypothesis

Central Venous Catheters (CVCs) are an essential part of the management of children undergoing treatment for cancer because they allow the safe administration of life-saving cancer drugs. Blood stream infection is a frequent and potentially serious complication of the use of CVCs. Some CVC associated infections can be treated by leaving the CVC where it is but frequently the best management involves taking the CVC out. Current methods of diagnosing CVC associated infection are unreliable with a result that more than 80% of CVCs removed for suspected infection are not in fact the source of infection. Also because of the difficulty in making a diagnosis, CVC associated infections may not be diagnosed or treated as early or as well as they can be.

In this study we will determine how best to use this test in children undergoing treatment for cancer and then find out if this new and relatively expensive test should be made available more widely.

In summary, we aim to find out whether the new test helps with the management of children with a central venous catheter, and improves the health outcomes.

Protocol can be found at http://www.hta.ac.uk/protocols/200300390013.pdf
More details can be found at http://www.hta.ac.uk/1449

Please note that, as of 27/08/2009, the anticipated end date of this trial has been updated from 30/11/2008 to 30/09/2009.

Ethics approval

No ethics information provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Central Venous Catheter Associated Infections

Intervention

There are two parts to the study:

In part one, we will determine how a novel molecular test for the diagnosis of CVC-associated infections performs in children being treated for cancer.

In the second part, we will determine the impact of the test as an adjunct to standard care on CVC management. Patients will be randomised to availability of the test plus standard care or standard care only.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

CVC survival

Secondary outcome measures

1. Duration of antibiotic treatment and hospitalisation for fever
2. Mortality
3. Economic analysis

Overall trial start date

01/06/2005

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Child, adolescent or young adult aged zero 18 years inclusive
2. Undergoing treatment for cancer/leukaemia or severe haematological disorders at a collaborating United Kingdom Children's Cancer Study Group (UKCCSG) centre
3. The routine standard of care requires a tunnelled single, double or triple lumen CVC or implanted vascular port
4. It is expected that the CVC or port will be required for a minimum of three months
5. Patients who already have an indwelling vascular access device in situ at the time of recruitment are eligible if they have been apyrexial and have not received intravenous antimicrobial therapy in the preceding two weeks
6. Written informed consent has been obtained from the parent/guardian and assent from the patient where appropriate
7. National/Local Ethical Committee approval has been obtained

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

330

Participant exclusion criteria

1. Failure to meet the above criteria
2. Patients with untunnelled CVCs or short term CVCs will not be included

Recruitment start date

01/06/2005

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Microbiology
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21294989

Publication citations

  1. Results

    Millar M, Zhou W, Skinner R, Pizer B, Hennessy E, Wilks M, Gilbert RE, Accuracy of bacterial DNA testing for central venous catheter-associated bloodstream infection in children with cancer., Health Technol Assess, 2011, 15, 7, 1-114, doi: 10.3310/hta15070.

Additional files

Editorial Notes