Evaluation of Viral Diagnostics on rEspiratory iNfections in ChildrEn
| ISRCTN | ISRCTN13015410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13015410 |
| Secondary identifying numbers | CCMO: NL13839.098.06 |
- 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
Scientific
Department of Pediatrics
Reinier de Graaf Hospital
PO Box 5011
Delft
2600GA
Netherlands
| Phone | +31 (0)15 260 3688 |
|---|---|
| wishaupt@rdgg.nl |
Study information
| Study design | Multicentre randomised controlled trial with blind allocation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/11/2007 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 2 Months |
| Sex | Both |
| Target number of participants | 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
2600GA
Netherlands
Sponsor information
Reinier de Graaf Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
PO Box 5011
Delft
2600 GA
Netherlands
| Website | http://www.rdgg.nl |
|---|---|
"ROR" |
https://ror.org/00wkhef66 |
Funders
Funder type
Hospital/treatment centre
Reinier de Graaf Hospital (Netherlands) - Research Activity Committee (WAC) (ref: 620604)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
