Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age

Bronchiolitis Clinical Trial

Official title:

Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age - the Clinical Relevance of Newly Discovered Viruses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00987519
• Other study ID #: VODP
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2009
• Last updated: July 6, 2010
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2009
• Source: University Medical Centre Ljubljana
• Contact: Marko Pokorn, MD, MSc
• Phone: +38641712241
• Email: marko.pokorn[@]mf.uni-lj.si
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

With the use of molecular methods new viruses have been detected in respiratory and gastrointestinal tracts of both patients and asymptomatic subjects in recent years. The clinical importance of these viruses has not been adequately studied.

The aim of this study is to use molecular methods to detect viruses in upper respiratory tract and gastrointestinal tract of children with acute bronchiolitis, acute gastroenteritis and febrile convulsions and to try to correlate the severity of clinical picture with the amount of viruses present in clinical samples. The investigators will also try to detect the increase in specific antibodies in paired sera.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1260
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

presence of

• acute bronchiolitis

• acute gastroenteritis

• febrile convulsion requiring hospital admission

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis
• Convulsion, Febrile
• Gastroenteritis
• Seizures
• Seizures, Febrile

Locations

Country	Name	City	State
Slovenia	Department of Infectious Diseases, University Medical Centre Ljubljana	Ljubljana
Slovenia	Department of Pediatric Surgery, University Medical Centre Ljubljana	Ljubljana
Slovenia	Institute of Microbiology and Immunology	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the clinical picture of a viral respiratory and/or gastrointestinal infection associated with a specific viral pathogen		In a 14-day period	No
Secondary	To correlate the severity of clinical picture with the quantity of virus in clinical samples		In a 14-day period	No