Respiratory Tract InfectionNCT00265187
The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.
An observational study of Respiratory Tract Infection and Children, run by HaEmek Medical Center, Israel at 3 sites in Israel.
Trial summary
Sputum specimens will be obtained from children < 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained. Read more about this study
- Who is it for?
- Ages 1 day to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infection, Children
- How many people
- 200 participants
- Where
- 3 sitesIsrael
- Study dates
- Dec 2005to Mar 2006
- 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 1 day to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 0-24 months hospitalized with acute bronchiolitis
Inclusion Criteria:Age 0-24 months, hospitalized children, -
Exclusion Criteria:Previous hospitalization, previous RSV immunization, immunocompromised patient, previous inclusion in this study, inclusion in another study.
-
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Pediatric department A, HaEmek Medical Center
Afula
Maier Hospital
Haifa
Pediatric Depart ment , Bnai Zion Hospital
Haifa
About this study
Official title: The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis in Northern Israel.
Sputum specimens will be obtained from children < 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained.
Read the detailed description
The purpose of the study is to asses the various pathogens of bronchiolitis in children and its' clinical manifestations. Prospective study in 3 Medical centers in Northern Israel. Included will be about 200 infants and children < 2 years hospitalized with bronchiolitis. From each child sputum specimen will be obtained and processed for HUMP - PCR, Pertussis - PCR, RSV - ELISA, DFA, PCR, Influenza A, B, Parainfluenza 1,2,3 - DFA, PCR, Adenovirus - DFA. Epidemiological data will be obtained for every child by structured questioner. Clinical data will be daily obtained by scoring system.
- Conditions
- Respiratory Tract Infection, Children
- Keywords
- child, bronchiolitis,
- Medical subject headings
- Respiratory Tract Infections, Bronchiolitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Dan Miron, MD, Principal investigator, HaEmek Medicak Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265187
- Sponsor's protocol ID
- 3350105
- Status last verified
- Aug 2006
- First submitted
- 13 Dec 2005
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis in Northern Israel.
- ClinicalTrials.gov ID
- NCT00265187
- Acronym / sponsor ID
- 3350105
- Conditions
- Respiratory Tract Infection, Children
- Keywords
- child, bronchiolitis,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 14 Dec 2005 (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.
Sputum specimens will be obtained from children < 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained.
Detailed description
The purpose of the study is to asses the various pathogens of bronchiolitis in children and its' clinical manifestations. Prospective study in 3 Medical centers in Northern Israel. Included will be about 200 infants and children < 2 years hospitalized with bronchiolitis. From each child sputum specimen will be obtained and processed for HUMP - PCR, Pertussis - PCR, RSV - ELISA, DFA, PCR, Influenza A, B, Parainfluenza 1,2,3 - DFA, PCR, Adenovirus - DFA. Epidemiological data will be obtained for every child by structured questioner. Clinical data will be daily obtained by scoring system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 0-24 months hospitalized with acute bronchiolitis
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
Related trials for Respiratory Tract Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Dan Miron, MD principal investigator
HaEmek Medicak Center, Afula, Israel
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 Respiratory Tract Infection and Children, run by HaEmek Medical Center, Israel at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 3 Jan 2013. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 3 Jan 2013.