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STRAP STudy to Reduce Antibiotic prescription in childhood Pneumonia


- candidate number22497
- NTR NumberNTR5326
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2015
- Secondary IDsZonMW 836041001 NL47593.078.14
- Public TitleSTRAP STudy to Reduce Antibiotic prescription in childhood Pneumonia
- Scientific TitleStudy to Reduce Antibiotic prescription in children Pneumonia: implementation of a validated decision rule to target antibiotic prescription in children with suspected community acquired pneumonia.
- ACRONYMSTRAP
- hypothesisThe 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) studiedPneumonia, Children, Antibiotics
- Inclusion criteriachildren aged 1 month 5 years with fever (parent reported and/or measured during physical examination T >38C) 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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate31-dec-2017
- Target number of participants1100
- 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 outcomeNumber 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
- TimepointsMonth 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
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R. Oostenbrink
- CONTACT for SCIENTIFIC QUERIESDr. R. Oostenbrink
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Innovatiefonds zorgverzekeraars
- Publications
- Brief summaryUnnecessary 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.
- Main changes (audit trail)
- RECORD23-jul-2015 - 17-okt-2015


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