Impact of introduction of real-time viral PCR on clinical decision making and costs in children with a respiratory tract infection.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Costs of viral PCR diagnostics. Cost changes as a result of introduction of PCR
diagnostics. Changes in clinical decision making: duration of hospital stay,
outpatient clinic visits, use of antibiotics, other medication. Use of the
viral PCR in daily clinical practice.
Secondary outcome
Epidemiology of respiratory tract infections in children. New viral pathogens.
Relation between viruses and laboratory parameters (CRP for example)
Background summary
Respiratory infections are encountered frequently in children. They account for
nearly 10% of the emergency visits and 20% of all pediatric hospital
admissions. The majority is of viral origin. At least 12 different virusses are
known to cause respiratory infection in children. All these virusses can be
detected with PCR techniques. The PCR results can be generated within 48 hours,
thereby
potentially influencing the treatment strategy. By introducing these
techniques, diagnostic costs may increase tremendously. Whether these
diagnsotic PCR-results are essential in clinical decision making is
questionable. In respiratory infection the role of the micro-organism is
overestimated. Other patient characteristics are important to tailor individual
treatment.
Study objective
Impact of introduction of real-time viral PCR on clinical decision making and
costs in children with a respiratory tract infection.
Study design
Randomized Clinical Trial
A cohort of 600 children is recruited in a peripheral teaching hospital
(Reinier de Graaf Groep, Delft) and an university hospital (ErasmusMC - Sophia)
during the first 2 years of the study. Clinical data are collected at entry of
the study by case record forms. The children will be randomized in 2 arms.
Treating physicians in arm A will receive the information of the PCR
diagnostics within 48 hours. Treating physicians in arm B will receive the
information of the PCR diagnostics after 4 weeks.
The 2 cohorts may reveal differences between the population in a peripheral
teaching hospital versus the patient population of the university hospital.
Intervention
Treating physicians in arm A will receive the information of the PCR
diagnostics within 48 hours
Study burden and risks
Several minutes of time will be asked at parents for gaining extra information
of the clinical history of their child.
There are no risks.
Postbus 5011
2600 GA Delft
NL
Postbus 5011
2600 GA Delft
NL
Listed location countries
Age
Inclusion criteria
Children under age of 2 months with a respiratory tract infection
Children older than 2 months with a respiratory tract infection and severe respiratory problems with tachypnea, dyspnea or cyanosis
Exclusion criteria
Age older than 12 years
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL13839.098.06 |