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?

Procalcitonin-guided antibiotic therapy for febrile neutropenia in children and young people with cancer. A single-arm pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13185152

Enrollment

Registered

2020-07-02

Start date

2020-10-01

Completion date

Unknown

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile neutropenia in children and young people undergoing treatment for cancer Cancer

Interventions

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

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 ha

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Lack of informed consent

Design outcomes

Primary

Measure	Time frame
Recruitment rate recorded as the number of eligible participants who consent to participate in the study over 6 months	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Contacts

Public ContactBob Phillips

bob.phillips@york.ac.uk07968727424

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026