Extrait

Background and study aims Neutropenic sepsis is a potentially life-threatening complication of chemotherapy caused by a condition known as neutropenia, in which the number of white blood cells (called neutrophils) in the blood is low. Neutrophils help the body to fight infection. People receiving chemotherapy for cancer treatment can be at risk of neutropenic sepsis because these treatments can temporarily lower the number of neutrophils in the blood. There is universal agreement that prompt antibiotic treatment is required, but less agreement about how best to manage patients thereafter. This study aims to find out whether changing from intravenous antibiotics (administered into a vein) to oral antibiotics on the first day of treatment is clinically and cost-effective in comparison with longer duration intravenous antibiotics in patients at low risk of complications. Who can participate? Patients undergoing chemotherapy who are admitted to hospital with low risk neutropenic sepsis. What does the study involve? Once you have consented you will undergo the required study tests and provide a blood sample, have your medical history and medications checked, and complete a short questionnaire. You will then be allocated to one of two groups. One group will switch from intravenous to oral antibiotics 12-24 hours after commencing intravenous treatment, for a total of five days antibiotic treatment. The other group will receive standard care intravenous antibiotics for at least 48 hours then either continue or switch to oral antibiotics at the doctor’s discretion. After leaving hospital you will take any remaining antibiotic tablets and complete a progress diary , and a nurse will phone you to check on your progress and go through two short questionnaires. What are the possible benefits and risks of participating? The results of this study will inform the future medical care of patients who develop neutropenic sepsis while undergoing chemotherapy. The potential benefits of participating include fewer complications with intravenous lines, earlier discharge from hospital, higher quality of life and more cost-effective treatment. The potential risks of participating include antibiotic treatment failure, side effects of antibiotic treatment, and mild discomfort when providing one additional blood sample. Where is the study run from? Belfast City Hospital, The Freeman Hospital, Leicester Royal Infirmary and Velindre Hospital (UK). When is the study starting and how long is it expected to run for? The study is due to start recruiting at four pilot sites in November 2015. If successful the main study will recruit for an additional 30 months in 12 sites across the UK. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? Dr Victoria Coyle [email protected]

Critère d'inclusion

• Patients with low risk neutropenic sepsis

Liens

• isrctn
• ictrp