|- candidate number||22497|
|- NTR Number||NTR5326|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jul-2015|
|- Secondary IDs||ZonMW 836041001 NL47593.078.14|
|- Public Title||STRAP – STudy to Reduce Antibiotic prescription in childhood Pneumonia|
|- Scientific Title||Study to Reduce Antibiotic prescription in children Pneumonia: implementation of a validated decision rule to target antibiotic prescription in children with suspected community acquired pneumonia.|
|- hypothesis||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?
|- Healt Condition(s) or Problem(s) studied||Pneumonia, Children, Antibiotics|
|- Inclusion criteria||children aged 1 month – 5 years with fever (parent reported and/or measured during physical examination T >38°C) with signs suspected of community acquired pneumonia (CAP)
|- Exclusion criteria||-febrile children with antibiotic treatment during the week prior to the ED visit|
-children with comorbidity, i.e. hemodynamic relevant cardiac disease, pulmonary, neurologic disease or (primary of secondary) immunodeficiency
-children with an obvious single other infectious focus (cutaneous, otitis media, rhinitis), those with signs of complicated pneumonia at the moment of presentation (i.e. respiratory failure, pleura empyema, pneumothorax, suspicion of septicaemia), those with (self-reported) intolerance of amoxicillin, and those with suspicion of resistant pathogens due to a visit to foreign countries 2 months prior to the ED visit
-patients not understanding or not able to act on safety-net instructions (due to language problems or logistics) in case of deterioration
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-okt-2015|
|- planned closingdate||31-dec-2017|
|- Target number of participants||1100|
|- Interventions||-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
|- Primary outcome||Number of (narrow-spectrum) antibiotic prescriptions and its percentage within the total included population (benefit); Strategy failures (children with complications of CAP within 7 days) (safety).|
|- Secondary outcome||-Compliance to the advice of the feverkidstool; percentage and number of narrow versus broad-spectrum antibiotic prescriptions; Duration and dosages of antibiotic prescriptions|
-Safety: Number of complications of pneumonia, association of isolated pathogens with complicated CAP course
|- Timepoints||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
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Oostenbrink|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Oostenbrink|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Innovatiefonds zorgverzekeraars|
|- Brief summary||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
To safely reduce antibiotic prescription by a clinical decision rule (Feverkidstool) in febrile children suspected of CAP.
Stepped wedge trial with implementation of the Feverkidstool guiding antibiotic treatment in children suspected of CAP in 7
Febrile children (1 month – 5 years) at the emergency care department with signs of CAP in 7 Dutch hospitals.
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.
Clinical decision rule (Feverkidstool) for the individual risk for CAP and other SBI guiding a targeted approach for antibiotic
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.
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.
M0-3: preparation; M4-15 datacollection preimplementation; M13-15 implementation; M16-M27 datacollection
postimplementation; M28-30 Datanalysis, reporting.
The Feverkidstool improves application of current insights on reduced antibiotic presicription in children suspected of CAP in
|- Main changes (audit trail)|
|- RECORD||23-jul-2015 - 17-okt-2015|