Molecular Diagnosis of Central Venous Catheter (CVC) associated infections

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2004
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. CONDITION: Central Venous Catheter Associated Infections ; Infections and Infestations ; Catheter infections PRIMARY OUTCOME: CVC survival SECONDARY OUTCOME: 1. Duration of antibiotic treatment and hospitalisation for fever; 2. Mortality ; 3. Economic analysis 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
Epistemonikos ID: 7630694c038b45107bd003fd526aef9519878e07
First added on: Aug 21, 2024