Molecular Diagnosis of Central Venous Catheter (CVC) associated infections
| ISRCTN | ISRCTN68138140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68138140 |
| Secondary identifying numbers | HTA 03/39/13; N0484156267 |
- Submission date
- 25/11/2004
- Registration date
- 14/12/2004
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Michael Millar
Scientific
Scientific
Department of Microbiology
37 Ashfield Street
Whitechapel
London
E1 1BB
United Kingdom
| Phone | +44 (0)20 73773078 |
|---|---|
| M.R.millar@qmul.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Molecular Diagnosis of Central Venous Catheter (CVC) associated infections |
| Study acronym | MD-CVC |
| Study objectives | 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(s) | No ethics information provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | CVC survival |
| Secondary outcome measures | 1. Duration of antibiotic treatment and hospitalisation for fever 2. Mortality 3. Economic analysis |
| Overall study start date | 01/06/2005 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 330 |
| Key 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 |
| Key exclusion criteria | 1. Failure to meet the above criteria 2. Patients with untunnelled CVCs or short term CVCs will not be included |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Microbiology
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2011 | Yes | No | |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link added.
