SinusitisNCT01492868
Sinusitis in Children and the Nasopharyngeal Microbiome
An observational study of Sinusitis, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the relationship between viral infections of the upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the risk of acute bacterial sinusitis over a one year period. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Sinusitis
- How many people
- 323 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jun 2017
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Healthy children
Who may be able to join
- Children 4 to 7 years of age
- Healthy
- English-speaking parent/guardian -
Who cannot join
- Any underlying condition which would predispose them to the development of sinusitis including congenital or acquired immunodeficiencies
- Craniofacial abnormalities
- Cystic fibrosis
- Allergic rhinitis or a previous episode of chronic sinusitis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UW Pediatrics at 20 S. Park St
Madison, Wisconsin, 53715
UW Health West Towne Pediatrics
Madison, Wisconsin, 53717
About this study
Official title: My Nose Study: Sinusitis in Children and How Virus Infections Promote Secondary Bacterial Infections
The purpose of this study is to investigate the relationship between viral infections of the upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the risk of acute bacterial sinusitis over a one year period. The investigators will determine the incidence of acute bacterial sinusitis post viral upper respiratory infection and identify the viral antecedent infections and other risk factors which predispose to infection and ultimately design strategies to reduce the burden of disease and antimicrobial resistance.
- Conditions
- Sinusitis
- Keywords
- sinusitis, upper respiratory infection
- Medical subject headings
- Sinusitis, Respiratory Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute bacterial sinusitis in children 49 to 84 months of age (which is the peak age incidence of sinusitis) as a complication of an antecedent viral upper respiratory infection.
Measured: Over a 1 year time frame
Secondary outcomes (1)
Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis.
Measured: Over a 1 year time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Ellen R Wald, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492868
- Sponsor's protocol ID
- 2015-0562
- Other IDs
- 1R01AI097172-01, 2011-0535, GRANT 10785179
- Status last verified
- May 2018
- First submitted
- 13 Dec 2011
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Nose Study: Sinusitis in Children and How Virus Infections Promote Secondary Bacterial Infections
- ClinicalTrials.gov ID
- NCT01492868
- Acronym / sponsor ID
- 2015-0562
- Conditions
- Sinusitis
- Keywords
- sinusitis, upper respiratory infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Dec 2011 (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.
The purpose of this study is to investigate the relationship between viral infections of the upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the risk of acute bacterial sinusitis over a one year period. The investigators will determine the incidence of acute bacterial sinusitis post viral upper respiratory infection and identify the viral antecedent infections and other risk factors which predispose to infection and ultimately design strategies to reduce the burden of disease and antimicrobial resistance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Healthy children
Key inclusion criteria (3 listed)
- Children 4 to 7 years of age
- Healthy
- English-speaking parent/guardian -
Key exclusion criteria (4 listed)
- Any underlying condition which would predispose them to the development of sinusitis including congenital or acquired immunodeficiencies
- Craniofacial abnormalities
- Cystic fibrosis
- Allergic rhinitis or a previous episode of chronic sinusitis.
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
Incidence of acute bacterial sinusitis in children 49 to 84 months of age (which is the peak age incidence of sinusitis) as a complication of an antecedent viral upper respiratory infection.
Time frame: Over a 1 year time frame
1 secondary outcome
Define relationships between the nasopharyngeal microbiome, viral illnesses, and progression to clinical sinusitis.
Time frame: Over a 1 year time frame
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 8 May 2018.
- University of Wisconsin-Madison Department of Pediatrics Research InformationLink provided by the sponsor.
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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.
Ellen R Wald, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, run by University of Wisconsin, Madison at 2 sites in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does the primary outcome measure?
Incidence of acute bacterial sinusitis in children 49 to 84 months of age (which is the peak age incidence of sinusitis) as a complication of an antecedent viral upper respiratory infection. (time frame: Over a 1 year time frame). It is what the study was designed to measure, not a finding.
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 8 May 2018.