Contact information
Type
Scientific
Primary contact
Mr Jérôme Wishaupt
ORCID ID
Contact details
Department of Pediatrics
Reinier de Graaf Hospital
PO Box 5011
Delft
2600GA
Netherlands
+31 (0)15 260 3688
wishaupt@rdgg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCMO: NL13839.098.06
Study information
Scientific title
Evaluation of viral diagnostics on respiratory infections in children: a multicentre randomised controlled trial
Acronym
EVIDENCE Trial
Study hypothesis
Introduction of real time polymer chain reaction (PCR) of 16 viruses and 2 bacteria for acute respiratory tract infections in children will not lead to major changes in clinical management and outcome.
Ethics approval
Regional Medical Ethics Committee (METC Zuidwest Holland [Voorburg]) approved on the 31st October 2006 (ref: METC-nr 06-067)
Study design
Multicentre randomised controlled trial with blind allocation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute respiratory infections
Intervention
In the intervention group, results of real-time PCR were communicated to the clinician within 48 hours. In the control group the same was provided, but after 4 weeks. Follow up time ended at discharge from the hospital.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Changes in clinical decision making:
1. Hospital admission yes or no: measured at first clinical presentation
2. Duration of hospital stay in days: measured after discharge at hospital
3. Start of antibiotics yes or no: measured at any time from first presentation until discharge
4. Duration of antibiotic use in days when initiated: measured after discharge
Secondary outcome measures
Epidemiology of respiratory tract infections in children; all measured at any time from first presentation until discharge:
1. Clinical symptoms and disease severity of new viral pathogens; are there differences between the pathogens?
2. Clinical symptoms and disease severity of multiple infections; differences with monoinfections
3. Relation between viruses and laboratory parameters (C-reactive protein [CRP] for example)
4. What is the role of Bordetella pertussis in children with acute respiratory infection and should it be tested routinely
5. Cost changes as a result of introduction of PCR diagnostics
Overall trial start date
01/11/2007
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children under age of 2 months with a respiratory tract infection
2. Children older than 2 months with a respiratory tract infection and severe respiratory problems with tachypnoea, dyspnoea or cyanosis
3. Gender: both male and female
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
600
Participant exclusion criteria
Aged older than 12 years
Recruitment start date
01/11/2007
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Pediatrics
Delft
2600GA
Netherlands
Sponsor information
Organisation
Reinier de Graaf Hospital (Netherlands)
Sponsor details
PO Box 5011
Delft
2600 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Reinier de Graaf Hospital (Netherlands) - Research Activity Committee (WAC) (ref: 620604)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21987698
Publication citations
-
Results
Wishaupt JO, Russcher A, Smeets LC, Versteegh FG, Hartwig NG, Clinical impact of RT-PCR for pediatric acute respiratory infections: a controlled clinical trial., Pediatrics, 2011, 128, 5, e1113-20, doi: 10.1542/peds.2010-2779.