STRAP – STudy to Reduce Antibiotic prescription in childhood Pneumonia

Unnecessary prescription of antibiotics highly contributes to the development of antibiotic resistance, a world wide threat to
health. We are in need to improve the recognition of children that benefit from antibiotic treatment for comunity-acquired
pneumonia (CAP).

Aim:

To safely reduce antibiotic prescription by a clinical decision rule (Feverkidstool) in febrile children suspected of CAP.

Design:

Stepped wedge trial with implementation of the Feverkidstool guiding antibiotic treatment in children suspected of CAP in 7
hospitals.
Population:
Febrile children (1 month – 5 years) at the emergency care department with signs of CAP in 7 Dutch hospitals.

Outcomes:

Primary: Number of antibiotic prescriptions (benefit); strategy failures within 7 days (safety). Secondary: Compliance to the rule;
Percentage of narrow spectrum antibiotics; Duration/doses of antibiotics; Complications of CAP; Costs of outcome measures.

Intervention:

Clinical decision rule (Feverkidstool) for the individual risk for CAP and other SBI guiding a targeted approach for antibiotic
prescription.
Analysis:
A generalized linear mixed model with antibiotic prescription as dependent will be used to correct for clustering in centers and
time-effects. Time-effects will be included as fixed effect. Covariates includes the predicted risk for CAP (low, intermediate and
high), patient age, triage urgency and season.
Power analysis:
A sample size of 1100 children with a suspicion of CAP in 24 months will be sensitive to detect an absolute reduction of 10%
(low risk) to 15% (intermediate risk) of antibiotic prescription with a power of 0.9 and an alpha of 0.05.
Schedule:
M0-3: preparation; M4-15 datacollection preimplementation; M13-15 implementation; M16-M27 datacollection
postimplementation; M28-30 Datanalysis, reporting.
Impact:
The Feverkidstool improves application of current insights on reduced antibiotic presicription in children suspected of CAP in
routine care.

Changes/Added information
dd 21-12-2016:
to provide sufficient inclusions we introduce an eighth hospital, Lange land hospital Zoetermeer

dd 20-8-2018
Interim analysis of inclusions during the first year showed a higher antibiotic prescription than previously assumed: in low risk children we observed 35-45% antibiotic prescription; in the intermediate group this is 40%. Therefore we assume a reduction of 15% in both the low and intermediate risk group. Remodelling with these numbers and similar assumptions as above shows that an effect of 15-20% antibiotic reduction can be assessed in a sample of 800-900 children.

The aim of this study is to reduce antibiotic prescriptions by use of a clinical decision rule in febrile children suspected for CAP with unchanged outcome. Specific research questions are:

1. Does a decision rule reduce the use of antibiotics in children with suspected CAP?

2. Does the use of a decision rule do not harm those whose treatment is modified as a result?

3. What is the compliance to a decision rule guiding clinicians on treatment for childhood CAP?

4. What is the cost benefit of the implementation of the feverkidstool in the diagnostic evaluation of a child suspected of CAP?

Month 1-3: Preparation study and preparation baseline data collection of eligible patients

Month 4-15: Preimplementation phase datacollection, development webbased dataregistry and feverkidstool. Evaluation possibilities to integrate the feverkidstool within the local ICT-environment
Month 13-15: Training ED personnel (nurses, paediatricians (in training)) in feverkidstool
Month 16-27: Postimplementation phase data collection of eligible patients (clinical characteristics, diagnoses and antibiotic therapy).

Month 28-30: Evaluation, datanalysis and interpretation; Writing report

-Feverkidstool: a clinical decision rule that assess the individual risk for pneumonia in children with fever

-a risk based strategy for treatment advice (discharge, watchfull waiting, or antibiotics) will be applied