Analyse costs and effects of point of care (POC) C-reactive protein (CRP) measurement in children with non-severe lower respiratory tract infection (LRTI) in primary care.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the % antibiotic prescriptions during 28 days after
first consultation.
Secondary outcome
Secondary outcomes include health care use, costs, adverse events, quality of
life (QOL), symptoms, and cost-effectiveness.
Background summary
Title of the study: Point-of-Care C-reactive protein to assist in primary care
management of children with lower respiratory tract infection
In children, lower respiratory tract infection (LRTI) is among the most
frequent reasons for consulting a general practitioner (GP). LRTI includes
pneumonia, which is a rare but severe infection, and acute bronchitis which is
merely self-limiting. Despite the fact that antibiotics are only recommended in
suspected pneumonia, the majority of children with LRTI in general practice are
still prescribed antibiotics.
We hypothesize that using POC CRP will help to reduce the proportion (%) of
children with non-severe LRTI treated with antibiotics without increasing
complications, and is cost effective compared to care as usual.
Study objective
Analyse costs and effects of point of care (POC) C-reactive protein (CRP)
measurement in children with non-severe lower respiratory tract infection
(LRTI) in primary care.
Study design
A cluster randomised controlled two arm trial with 28 days follow up.
Intervention
GP practices are randomised to usual care, or usual care plus POC CRP. 22
practices from three different regions in the Netherlands will be involved
(Utrecht, Rotterdam and Maastricht). Children can also be included at an
out-of-hours service, These patients will be randomised individually. In total
354 patients will be included (177 in each arm).
Study burden and risks
We hypothesize that POC CRP will reduce the proportion (%) of children with
non-severe LRTI treated with antibiotics without increasing complications.
Therefore we expect the number of events to be comparable within both study
arms and without an increased risk for the patients because of participation in
the study. The risk related to the blood drawn from a finger prick, the only
invasive test related to the study, is negligible.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Children aged between 3 months and 12 years presenting to the GP with a non-severe LRTI.
- LRTI will be defined as acute cough (shorter than 21 days) with (reported) fever (>38 °C).
- The parent of the patient should be able to provide written informed consent and be willing to (help to) complete the patient diary.
Exclusion criteria
- immunodeficiency
- 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;Being severely ill or highly suspected of pneumonia includes: signs of dehydration, cyanosis, tachypnoe, lower level of consciousness or fever during > 5 days, no food or fluid intake, or otherwise judged as being severely ill by the GP.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45601.041.13 |
| OMON | NL-OMON22451 |