BronchiolitisNCT00987519
Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age
An observational study of Bronchiolitis and Gastroenteritis, run by University Medical Centre Ljubljana at 3 sites in Slovenia.
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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis, Gastroenteritis, Convulsion, Febrile
- How many people
- 1,260 participants
- Where
- 3 sitesSlovenia
- Study dates
- Oct 2009to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- presence of
- acute bronchiolitis
- acute gastroenteritis
- febrile convulsion requiring hospital admission
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites, 3 recruiting
- Recruiting
Department of Infectious Diseases, University Medical Centre Ljubljana
Ljubljana, 1000
Marko Pokorn, MD, +38641712241, marko.pokorn@mf.uni-lj.si
Tatjana Mrvič, MD, +38615222110, tatjana.mrvic@guest.arnes.si
- Recruiting
Department of Pediatric Surgery, University Medical Centre Ljubljana
Ljubljana, 1000
Štefan Grosek, MD, PhD, +38615228137, stefan.grosek@guest.arnes.si
Štefan Grosek, MD, PhD
- Not yet recruiting
Institute of Microbiology and Immunology
Ljubljana, 1000
Miroslav Petrovec, MD, PhD, +38615437452, mirc.petrovec@mf.uni-lj.si
Monika Jevšnik, BSc, +38615437452, moni.jevsnik@gmail.com
About this study
Official title: Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age - the Clinical Relevance of Newly Discovered Viruses
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.
- Conditions
- Bronchiolitis, Gastroenteritis, Convulsion, Febrile
- Keywords
- acute bronchiolitis, acute gastroenteritis, febrile convulsion, viral agents, molecular methods
- Medical subject headings
- Bronchiolitis, Gastroenteritis, Seizures, Febrile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the clinical picture of a viral respiratory and/or gastrointestinal infection associated with a specific viral pathogen
Measured: In a 14-day period
Secondary outcomes (1)
To correlate the severity of clinical picture with the quantity of virus in clinical samples
Measured: In a 14-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Investigators
- Marko Pokorn, MD, MSc, Principal investigator, Department of Infectious Diseases, University Medical Centre LjubljanaFranc Strle, MD, PhD, Study chair, Department of Infectious Diseases, University Medical Centre LjubljanaMiroslav Petrovec, MD, PhD, Principal investigator, Institute of Microbiology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987519
- Sponsor's protocol ID
- VODP
- Status last verified
- Oct 2009
- First submitted
- 30 Sep 2009
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Jevsnik Virant M, Petrovec M, Strle F, Mrvic T, Pokorn M, Grosek S, Ursic T. Influenza C Virus in Children With Acute Bronchiolitis and Febrile Seizures. Pediatr Infect Dis J. 2026 May 1;45(5):432-436. doi: 10.1097/INF.0000000000005089. Epub 2025 Dec 15.
PubMed 41392358Pokorn 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.
PubMed 27698149Jevsnik 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.
PubMed 27171141Jevsnik 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.
PubMed 23379823
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age - the Clinical Relevance of Newly Discovered Viruses
- ClinicalTrials.gov ID
- NCT00987519
- Acronym / sponsor ID
- VODP
- Conditions
- Bronchiolitis, Gastroenteritis, Convulsion, Febrile
- Keywords
- acute bronchiolitis, acute gastroenteritis, febrile convulsion, viral agents, molecular methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,260 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- presence of
- acute bronchiolitis
- acute gastroenteritis
- febrile convulsion requiring hospital admission
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To correlate the severity of clinical picture with the quantity of virus in clinical samples
Time frame: In a 14-day period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
- Derived from this study: PubMed 41392358Jevsnik Virant M, Petrovec M, Strle F, Mrvic T, Pokorn M, Grosek S, Ursic T. Influenza C Virus in Children With Acute Bronchiolitis and Febrile Seizures. Pediatr Infect Dis J. 2026 May 1;45(5):432-436. doi: 10.1097/INF.0000000000005089. Epub 2025 Dec 15.
- Derived from this study: PubMed 27698149Pokorn 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.
- Derived from this study: PubMed 27171141Jevsnik 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.
- Derived from this study: PubMed 23379823Jevsnik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Pokorn, MD, MSc principal investigator
Department of Infectious Diseases, University Medical Centre Ljubljana
Franc Strle, MD, PhD study chair
Department of Infectious Diseases, University Medical Centre Ljubljana
Miroslav Petrovec, MD, PhD principal investigator
Institute of Microbiology and Immunology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis and Gastroenteritis, run by University Medical Centre Ljubljana at 3 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marko Pokorn, MD, MSc (+38641712241, marko.pokorn@mf.uni-lj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.