Evaluation of Viral Diagnostics on rEspiratory iNfections in ChildrEn

ISRCTN	ISRCTN13015410
DOI	https://doi.org/10.1186/ISRCTN13015410
Protocol serial number	CCMO: NL13839.098.06
Sponsor	Reinier de Graaf Hospital (Netherlands)
Funder	Reinier de Graaf Hospital (Netherlands) - Research Activity Committee (WAC) (ref: 620604)

Submission date: 15/11/2010
Registration date: 23/12/2010
Last edited: 26/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jérôme Wishaupt
Scientific

Department of Pediatrics
Reinier de Graaf Hospital
PO Box 5011
Delft
2600GA
Netherlands

Phone	+31 (0)15 260 3688
Email	wishaupt@rdgg.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial with blind allocation
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of viral diagnostics on respiratory infections in children: a multicentre randomised controlled trial
Study acronym	EVIDENCE Trial
Study objectives	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(s)	Regional Medical Ethics Committee (METC Zuidwest Holland [Voorburg]) approved on the 31st October 2006 (ref: METC-nr 06-067)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	2 Months
Sex	All
Target sample size at registration	600
Key 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
Key exclusion criteria	Aged older than 12 years
Date of first enrolment	01/11/2007
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Pediatrics

Delft
2600GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes