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PRICE onderzoek: Het gebruik van een CRP test in de huisartsenpraktijk bij de behandeling van kinderen met een lage luchtweginfectie


- candidate number16049
- NTR NumberNTR4399
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2014
- Secondary IDsNL45601.041.13 
- Public TitlePRICE onderzoek: Het gebruik van een CRP test in de huisartsenpraktijk bij de behandeling van kinderen met een lage luchtweginfectie
- Scientific TitlePoint-of-Care C-reactive protein to assist in primary care management of children with lower respiratory tract infection
- ACRONYMPRICE
- hypothesisPoint of care measurement of C-reactive protein in children with non severe lower respiratory tract infection in primary care will reduce the proportion of children treated with antibiotics without increasing complications, and is cost effective compared to care as usual
- Healt Condition(s) or Problem(s) studiedLower respiratory tract infections, Children
- Inclusion criteria-Children aged between 3 months and 12 years -Presenting to the GP with a non-severe LRTI: acute cough (shorter than 21 days) with (reported) fever (>38 °C, shorter than 5 days) -Parents of the patient should be able to provide written informed consent and be willing to complete the patient diary.
- Exclusion criteria-Immunodeficiency -Underlying severe pulmonary disease like Cystic Fibrosis, Bronchopulmonary Dysplasia, congenital pulmonary defects -Serious congenital defects, such as Down syndrome, congenital heart defects, neuromuscular disease, severe developmental retardation -recent (previous four weeks) use of systemic antibiotics and/or corticosteroids -being severely ill as judged by the GP based on symptoms and signs -highly suspected of having pneumonia -referral to specialist or emergency department deemed necessary by GP
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jan-2014
- planned closingdate1-mei-2015
- Target number of participants354
- InterventionsGP practices are randomised to usual care, or usual care plus point of care CRP. All parents are asked to fill out a 28-day online diary about the child's symptoms, health care use and costs
- Primary outcomeAntibiotic reduction expressed in the percentage of children prescribed antibiotics in the first 28 days after consultation, as compared to a strategy without POC CRP measurement (usual care)
- Secondary outcome-Health care use -Costs -Adverse events -Quality of life (QOL) -Functional Health status -Symptoms -Cost-effectiveness
- Timepointsprimary outcome after 28 days secondary outcome after 3 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.J.C. Schot
- CONTACT for SCIENTIFIC QUERIES B.D.L. Broekhuizen
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, SALTRO - Doctor Laboratory & Thrombosis Service, Star Medisch Diagnostisch Centrum (Star-MDC), Axis Shield
- Publications
- Brief summaryRationale: LRTI is one of the most common reasons to consult a general practitioner (GP) in children. Despite the fact that antibiotics are only recommended in suspected pneumonia, the majority of children presenting with acute bronchitis are prescribed antibiotics. point of care (POC) C-reactive protein (CRP) measurement has shown to reduce antibiotic prescribing for lower respiratory tract infection in adults without compromising patients’ recovery and satisfaction with care. In children however, no evidence is yet available. Objective: To analyse costs and effects of POC CRP measurement in children with non-severe lower respiratory tract infection (LRTI) in primary care. Study design: Cluster randomised controlled two arm trial with 28 days follow up. GP practices are randomised to usual care, or usual care plus POC CRP. Twenty-two practices from Utrecht, Rotterdam and Maastricht areas will be involved, a total of 356 children will particpate. Study population: Children between 3 months and 12 years presenting with non-severe LRTI. Study endpoints: Primary outcome is antibiotic reduction expressed in the % of children prescribed antibiotics in the first 28 days after consultation, as compared to a strategy without POC CRP measurement (usual care). Secondary outcomes include health care use, costs, adverse events, functional health status, symptoms and cost-effectiveness.
- Main changes (audit trail)
- RECORD14-jan-2014 - 8-apr-2014


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