No registrations found.
ID
Source
Brief title
Health condition
Children with non severe lower respiratory tract infections
Sponsors and support
Intervention
Outcome measures
Primary outcome
Antibiotic 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
Background summary
Rationale: 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.
Study objective
Point 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
Study design
primary outcome after 28 days
secondary outcome after 3 months
Intervention
GP 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
P.O. Box 85500, Correspondence Str. 6.131
M.J.C. Schot
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 68362 / +31 (0)619631455
m.j.c.schot-2@umcutrecht.nl
P.O. Box 85500, Correspondence Str. 6.131
M.J.C. Schot
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 68362 / +31 (0)619631455
m.j.c.schot-2@umcutrecht.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4263 |
| NTR-old | NTR4399 |
| CCMO | NL45601.041.13 |
| OMON | NL-OMON41688 |