Condition category
Respiratory
Date applied
15/11/2010
Date assigned
23/12/2010
Last edited
26/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.rdgg.nl

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

  1. 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.

Additional files

Editorial Notes