Skip to content

Evaluation of Viral Diagnostics on rEspiratory iNfections in ChildrEn

Evaluation of viral diagnostics on respiratory infections in children: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13015410
Enrollment
600
Registered
2010-12-23
Start date
2007-11-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory infections Respiratory Acute upper respiratory infections

Interventions

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

Sponsors

Reinier de Graaf Hospital (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Aged older than 12 years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026