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Contact Information:

Dr Bob Phillips
07968727424
bob.phillips@york.ac.uk


Dr Bob Phillips
07968727424
bob.phillips@york.ac.uk


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Be Part of Research - Trial Details - Is it practical to perform a study to manage antibiotic delivery in febrile neutropenia for children and young people undergoing treatment with anti-cancer drugs with the routine serial use of PCT measurements?
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Is it practical to perform a study to manage antibiotic delivery in febrile neutropenia for children and young people undergoing treatment with anti-cancer drugs with the routine serial use of PCT measurements?

Not Recruiting

Open to: All Genders

Age: Mixed

Leeds

Medical Conditions

Febrile neutropenia in children and young people undergoing treatment for cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


A blood test called procalcitonin (PCT) can help to show who has a severe infection. Researchers now want to show that it’s safe to use this test to shorten the amount of time children spend on antibiotics. Ideally they need to undertake a very large ‘supertanker’ of a study, with hundreds of children, half getting the PCT-test management and half not getting it, to test if this really makes a difference. In order to do this though, they need to firstly check that it is possible – that the patients, families and doctors will be prepared to take part in such a study. This is what this study is for; a pilot study, to make sure that the big ‘supertanker’ is feasible. This pilot study will work with 10-20 families who agree to have their FN managed this way. It will see if it is possible to do the blood tests quickly, act on the results, and send children home. The researchers will discuss with doctors, nurses, ANP (advanced nurse practitioners) and the families to hear about and understand their views on this way of managing infections. They will also look to see what proportion of people who might have been able to take part in the study agreed to do so. These findings will be used to work out whether the supertanker study is possible and how to do it well.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Oct 2020 01 Mar 2021

Publications

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36053620/ (added 10/11/2023)

When a child is admitted with febrile neutropenia they will have an extra blood sample taken when routine blood samples are taken from their central line. The extra blood will be taken when they come into the ward (day 1), and of each subsequent day of the admission while they are being treated for febrile neutropenia. The extra amount of blood taken each time will be about 5 ml (one teaspoon). For children where a blood test is not routinely planned on day 2 the researchers would still need to take a blood sample on day 2 for the study. Every time the child is admitted with febrile neutropenia the researchers will want to take the same set of samples until the study ends. The maximum number of samples taken per episode will be seven. The blood samples will be tested and used to measure procalcitonin; if these levels are low or fall dramatically, the clinical team will discuss stopping antibiotic therapy, even if the child’s temperature has not been low for more than 48 hours. Families will also have the option to participate in an interview over the phone or in person. This will involve answering questions about their and their child’s experiences; the child may also wish to take part. This should not take any longer about 30 minutes. The interview will be recorded using a secure audio device, and parts of the interview typed into an anonymized document. Once the study has been completed the audio recording will be deleted.


Children aged birth to 18 years with cancer or cancer-like conditions who are currently having systemic anticancer treatment and at risk of developing febrile neutropenia, and under treatment in the Leeds Children's Hospital Paediatric Haematology and Oncology Department

You can take part if:



You may not be able to take part if:


Lack of informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leeds Children's Hospital
    Great George Street
    Leeds
    LS1 9TX

Where possible, extra blood samples will be taken at the same time as routine blood sampling. For some children, an extra sample of blood may need to be taken during the admission from their central line when routine bloods were not. Reducing the amount of antibiotic used for an episode of FN might mean participants will need to be re-admitted if an infection recurs. This study will add to the information already available about the use of inflammatory biomarkers, and how they may be safely used to reduce antibiotic use as duration of stay in hospital.

Dr Bob Phillips
07968727424
bob.phillips@york.ac.uk


Dr Bob Phillips
07968727424
bob.phillips@york.ac.uk



The study is sponsored by Leeds Teaching Hospitals NHS Trust and funded by Candlelighters.



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Read full details for Trial ID: ISRCTN13185152
Last updated 10 November 2023

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