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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University Medical Centre Ljubljana.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00987519
First received: September 30, 2009
Last updated: July 6, 2010
Last verified: October 2009
History of Changes
  Purpose

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.


Condition
Bronchiolitis
Gastroenteritis
Convulsion, Febrile

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age - the Clinical Relevance of Newly Discovered Viruses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • To describe the clinical picture of a viral respiratory and/or gastrointestinal infection associated with a specific viral pathogen [ Time Frame: In a 14-day period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate the severity of clinical picture with the quantity of virus in clinical samples [ Time Frame: In a 14-day period ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, stool and nasopharyngeal swab samples.


Estimated Enrollment: 1260
Study Start Date: October 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute bronchiolitis
Patients with acute bronchiolitis - the presence of nasal discharge, cough, wheezing and/or crackles on lung auscultation.
Acute gastroenteritis
Patients with 3 or more loose or liquid stools in 24 hours prior to entering the study.
Febrile convulsion
Patients with a cerebral paroxysm accompanied by fever without signs of central nervous system infection.
Control group
Patients referred to pediatric surgery for elective surgical procedure - judged to be free of clinical signs and symptoms of infection.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

presence of

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987519

Contacts
Contact: Marko Pokorn, MD, MSc +38641712241 marko.pokorn@mf.uni-lj.si
Contact: Tatjana Mrvič, MD, MSc +38615222110 tatjana.mrvic@guest.arnes.si

Locations
Slovenia
Department of Infectious Diseases, University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Marko Pokorn, MD     +38641712241     marko.pokorn@mf.uni-lj.si    
Contact: Tatjana Mrvič, MD     +38615222110     tatjana.mrvic@guest.arnes.si    
Sub-Investigator: Tatjana Mrvič, MD, MSc            
Principal Investigator: Marko Pokorn, MD, MSc            
Department of Pediatric Surgery, University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Štefan Grosek, MD, PhD     +38615228137     stefan.grosek@guest.arnes.si    
Principal Investigator: Štefan Grosek, MD, PhD            
Institute of Microbiology and Immunology Not yet recruiting
Ljubljana, Slovenia, 1000
Contact: Miroslav Petrovec, MD, PhD     +38615437452     mirc.petrovec@mf.uni-lj.si    
Contact: Monika Jevšnik, BSc     +38615437452     moni.jevsnik@gmail.com    
Principal Investigator: Miroslav Petrovec, MD, PhD            
Sub-Investigator: Monika Jevšnik, BSc            
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Investigators
Principal Investigator: Marko Pokorn, MD, MSc Department of Infectious Diseases, University Medical Centre Ljubljana
Study Chair: Franc Strle, MD, PhD Department of Infectious Diseases, University Medical Centre Ljubljana
Principal Investigator: Miroslav Petrovec, MD, PhD Institute of Microbiology and Immunology
  More Information

No publications provided by University Medical Centre Ljubljana

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marko Pokorn, MD, MSc, Department of Infectious Diseases, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00987519     History of Changes
Other Study ID Numbers: VODP
Study First Received: September 30, 2009
Last Updated: July 6, 2010
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
acute bronchiolitis
acute gastroenteritis
febrile convulsion
viral agents
molecular methods

Additional relevant MeSH terms:
Gastroenteritis
Bronchiolitis
Seizures
Seizures, Febrile
Fever
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Tract Infections
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Body Temperature Changes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013