Clinical trial NCT00987519: Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age
Official title: Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age - the Clinical Relevance of Newly Discovered Viruses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiolitis
Gastroenteritis
Convulsion, Febrile
Keywords: acute bronchiolitis
acute gastroenteritis
febrile convulsion
viral agents
molecular methods
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2009-10-01
Enrollment: 1260
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 6 years of age admitted to Department of Infectious Diseases, University Medical Centre Ljubljana with a diagnosis of acute bronchiolitis, acute gastroenteritis or febrile convulsion.

Brief 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.


Eligibility criteria: Inclusion Criteria:

presence of

* acute bronchiolitis
* acute gastroenteritis
* febrile convulsion requiring hospital admission

Exclusion Criteria:

* none

Primary outcomes:
measure: To describe the clinical picture of a viral respiratory and/or gastrointestinal infection associated with a specific viral pathogen
timeFrame: In a 14-day period
Secondary outcomes:
measure: To correlate the severity of clinical picture with the quantity of virus in clinical samples
timeFrame: In a 14-day period
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Infectious Diseases, University Medical Centre Ljubljana
city: Ljubljana
country: Slovenia
facility: Department of Pediatric Surgery, University Medical Centre Ljubljana
city: Ljubljana
country: Slovenia
facility: Institute of Microbiology and Immunology
Study officials:
affiliation: Department of Infectious Diseases, University Medical Centre Ljubljana
name: Marko Pokorn, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Infectious Diseases, University Medical Centre Ljubljana
name: Franc Strle, MD, PhD
role: STUDY_CHAIR
affiliation: Institute of Microbiology and Immunology
name: Miroslav Petrovec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pokorn M, Jevsnik M, Petrovec M, Steyer A, Mrvic T, Grosek S, Lusa L, Strle F. Respiratory and Enteric Virus Detection in Children. J Child Neurol. 2017 Jan;32(1):84-93. doi: 10.1177/0883073816670820. Epub 2016 Oct 3.
citation: Jevsnik M, Steyer A, Pokorn M, Mrvic T, Grosek S, Strle F, Lusa L, Petrovec M. The Role of Human Coronaviruses in Children Hospitalized for Acute Bronchiolitis, Acute Gastroenteritis, and Febrile Seizures: A 2-Year Prospective Study. PLoS One. 2016 May 12;11(5):e0155555. doi: 10.1371/journal.pone.0155555. eCollection 2016.
citation: Jevsnik M, Steyer A, Zrim T, Pokorn M, Mrvic T, Grosek S, Strle F, Lusa L, Petrovec M. Detection of human coronaviruses in simultaneously collected stool samples and nasopharyngeal swabs from hospitalized children with acute gastroenteritis. Virol J. 2013 Feb 5;10:46. doi: 10.1186/1743-422X-10-46.