Plain English Summary
Background and study aims
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.
Who can participate?
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
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
Leeds Children's Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2020 to April 2021
Who is funding the study?
Candlelighters (UK)
Who is the main contact?
Dr Bob Phillips
bob.phillips@york.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Bob Phillips
ORCID ID
http://orcid.org/0000-0002-4938-9673
Contact details
Alcuin College
University of York
York
YO10 5DD
United Kingdom
07968727424
bob.phillips@york.ac.uk
Type
Public
Additional contact
Dr Bob Phillips
ORCID ID
http://orcid.org/0000-0002-4938-9673
Contact details
Alcuin College
University of York
York
YO10 5DD
United Kingdom
07968727424
bob.phillips@york.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 279915
Study information
Scientific title
Procalcitonin-guided antibiotic therapy for febrile neutropenia in children and young people with cancer. A single-arm pilot study
Acronym
PAnTHer-cub
Study hypothesis
The hypothesis is: serial procalcitonin will indicate more rapidly than fever which children and young people do not have a serious bacterial infection and in whom their antibiotics can be stopped, and that parents and clinical teams will be happy to undertake such a study to see (in a larger trial) if it is clinically and cost-effective.
Ethics approval
Approval pending
Study design
Single-arm unblinded study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Febrile neutropenia in children and young people undergoing treatment for cancer
Intervention
Single-arm study: procalcitonin-guided management of antibiotic duration; to consider discontinuing empiric antibiotics if repeat PCT measurements are <80% of peak or <2, whichever is the higher value.
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.
Follow-up: 7 days after stopping antibiotics.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Recruitment rate recorded as the number of eligible participants who consent to participate in the study over 6 months
Secondary outcome measures
1. Discontinuation adherence: proportion of episodes where antibiotics stopped according to PCT-guided recommendation over 6 months
2. Safety: number potentially infection-related admissions to critical care after discontinuation of antibiotics over 6 months
3. Recruitment strategy: proportion of potentially eligible patients who were approached to consent over 6 months
4. Attrition: proportion of enrolled patients who then discontinued or declined intervention over 6 months
5. Data quality: proportion of missing data on primary outcome measures over 6 months
6. Impact on PCT on clinical decision making and reasons for adherence and non-adherence (qualitative data)
7. Patient, parent and clinician attitudes to study (qualitative data) including the outcomes important to CYP/families
Overall trial start date
01/01/2020
Overall trial end date
01/04/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
10
Participant exclusion criteria
Lack of informed consent
Recruitment start date
01/09/2020
Recruitment end date
01/03/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Children's Hospital
Great George Street
Leeds
LS1 9TX
United Kingdom
Sponsor information
Organisation
Leeds Teaching Hospitals NHS Trust
Sponsor details
Great George Street
Leeds
LS1 9TX
United Kingdom
+44 (0)1133922000
ltht.researchoffice@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Candlelighters
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in an academic environment and lay-summaries in openly accessible sites. A protocol is not planned to be made publicly available.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Bob Phillips (bob.phillips@york.ac.uk). IPD will be available from the key infectious outcomes (documented infection, duration of antibiotic therapy) and key presentation details (max temp, blood count, global assessment of illness severity) and non-identifiable patient data (age in years, broad diagnostic grouping). Raw qualitative data will not be available because of the impracticality of de-identification. Specific consent for such sharing will be requested. Such requests will be considered by the trial management team only after the primary study has been published.
Intention to publish date
01/09/2021
Participant level data
Available on request
Basic results (scientific)
Publication list