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

NCT ID: NCT00987519

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchiolitis Gastroenteritis Convulsion, Febrile

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Patients referred to pediatric surgery for elective surgical procedure - judged to be free of clinical signs and symptoms of infection.

No interventions assigned to this group

Acute bronchiolitis

Patients with acute bronchiolitis - the presence of nasal discharge, cough, wheezing and/or crackles on lung auscultation.

No interventions assigned to this group

Acute gastroenteritis

Patients with 3 or more loose or liquid stools in 24 hours prior to entering the study.

No interventions assigned to this group

Febrile convulsion

Patients with a cerebral paroxysm accompanied by fever without signs of central nervous system infection.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

presence of

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

Exclusion Criteria

* none
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ljubljana School of Medicine, Slovenia

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Infectious Diseases, University Medical Centre Ljubljana

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marko Pokorn, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases, University Medical Centre Ljubljana

Franc Strle, MD, PhD

Role: STUDY_CHAIR

Department of Infectious Diseases, University Medical Centre Ljubljana

Miroslav Petrovec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Microbiology and Immunology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Infectious Diseases, University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Department of Pediatric Surgery, University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Institute of Microbiology and Immunology

Ljubljana, , Slovenia

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Slovenia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marko Pokorn, MD, MSc

Role: CONTACT

+38641712241

Tatjana Mrvič, MD, MSc

Role: CONTACT

+38615222110

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marko Pokorn, MD

Role: primary

+38641712241

Tatjana Mrvič, MD

Role: backup

+38615222110

Štefan Grosek, MD, PhD

Role: primary

+38615228137

Miroslav Petrovec, MD, PhD

Role: primary

+38615437452

Monika Jevšnik, BSc

Role: backup

+38615437452

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27698149 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27171141 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23379823 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VODP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.