Condition category
Cancer
Date applied
01/07/2020
Date assigned
02/07/2020
Last edited
04/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

Approved 28/08/2020, West Midlands - Black Country REC (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8284; blackcountry.rec@hra.nhs.uk), ref: 20/WM/0205

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

01/10/2020

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

https://www.leedsth.nhs.uk/research

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

Publication citations

Additional files

Editorial Notes

04/09/2020: The following changes were made to the trial record: 1. The ethics approval was added. 2. The recruitment start date was changed from 01/09/2020 to 01/10/2020. 02/07/2020: Trial's existence confirmed by Leeds Teaching Hospitals NHS Trust.