Otitis MediaOMVacNCT00847756
Host-pathogen Interaction in Otitis Media
An observational study of Otitis Media, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason for children to visit a physician. In many countries it is the most common reason to prescribe antibiotics leading to increased drug-resistance of the causative agents, or to undergo surgery. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- questionnaire, blood sample and collection of middle ear fluid
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2008to Jul 2011
- 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
- No healthy volunteers
- Child
Study population: Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion
Who may be able to join
- children up to 5 years of age
- suffering from rAOM, COME or CSOM
- waiting for tympanostomy tube insertion
- informed consent
Who cannot join
- No informed consent
- The child has a malignancy, or organ transplantation, or immune deficiency in the medical history
- The child had recent elective ear surgery (i.e. mastoidectomy, implants <2 weeks ago)
- The child suffers from systemic infectious diseases (i.e. hepatitis, chickenpox)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Canisius Wilhelmina hospital, Department of otorhinolaryngology
Nijmegen, 6500 HB
Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology
Nijmegen, 6500 HB
About this study
Official title: Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media
Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason for children to visit a physician. In many countries it is the most common reason to prescribe antibiotics leading to increased drug-resistance of the causative agents, or to undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5 billion dollar annually in the United States. Prevention is suspected to be an important solution to this problem.
Although OM management has no universal standard yet, it may imply watchful waiting, antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future) vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within 2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly detected OME resolves within 3 months. However, in a significant part of the OM population persistent or recurrent episodes of OM are responsible for a significant morbidity for both children and parents, despite variable treatment options.
Through the set up of a new prospective cohort in a clinical setting, relevant patient characteristics, the role of bacterial and viral pathogens, the role of recurrent infection in relation to biofilm formation, and the host response at protein level will be studied in detail. This project is expected to increase the understanding of the underlying mechanisms of OM disease, which will support future treatment and prevention strategies. Better understanding in OM pathogenesis is warranted in order to develop these novel preventive strategies.
- Conditions
- Otitis Media
- Being tested
- questionnaire, blood sample, collection of middle ear fluid, nasopharyngeal swab
- Keywords
- Otitis media, demography, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, rhinovirus, children, 0-5 years of age, diagnosed rAOM, COME or CSOM by an otorhinolaryngologist, primary and secondary hospital Nijmegen, the Netherlands
- Medical subject headings
- Otitis Media, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Identification of risk factors
blood sampleProcedure or surgery
venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.
collection of middle ear fluidProcedure or surgery
During routine surgery middle ear fluids are collected per patient.
nasopharyngeal swabProcedure or surgery
A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.
| Study group | Role | What they receive |
|---|---|---|
| rAOM | Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion. Receives: Other: questionnaire; Procedure: blood sample; Procedure: collection of middle ear fluid; Procedure: nasopharyngeal swab | |
| COME | Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion. Receives: Other: questionnaire; Procedure: blood sample; Procedure: collection of middle ear fluid; Procedure: nasopharyngeal swab | |
| CSOM | Children 0-5 years of age suffering from chronic suppurative otitis media and waiting for tympanostomy tube insertion. Note: Only 3 patients with CSOM were recruited and therefore not suitable for publication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease
Measured: 01-06-2009 to 01-06-2010
Secondary outcomes (4)
Otitis media demography
Measured: 15-04-2008 to 01-01-2010
Bacterial and viral pathogen detection
Measured: 15-04-2008 to 01-01-2010
Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens
Measured: 15-04-08 to 01-01-2010
Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis
Measured: 01-06-2009 to 01-06-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies 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
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ronald de Groot, MD, PhD, Study chair, Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the NetherlandsKim Stol, MD, Principal investigator, Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847756
- Sponsor's protocol ID
- OMVac clinical study
- Other IDs
- EU-FP6
- Acronym
- OMVac
- Status last verified
- Dec 2010
- First submitted
- 18 Feb 2009
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media
- ClinicalTrials.gov ID
- NCT00847756
- Acronym / sponsor ID
- OMVac / OMVac clinical study
- Conditions
- Otitis Media
- Keywords
- Otitis media, demography, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, rhinovirus, children, 0-5 years of age, diagnosed rAOM, COME or CSOM by an otorhinolaryngologist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 19 Feb 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.
Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason for children to visit a physician. In many countries it is the most common reason to prescribe antibiotics leading to increased drug-resistance of the causative agents, or to undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5 billion dollar annually in the United States. Prevention is suspected to be an important solution to this problem.
Although OM management has no universal standard yet, it may imply watchful waiting, antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future) vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within 2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly detected OME resolves within 3 months. However, in a significant part of the OM population persistent or recurrent episodes of OM are responsible for a significant morbidity for both children and parents, despite variable treatment options.
Through the set up of a new prospective cohort in a clinical setting, relevant patient characteristics, the role of bacterial and viral pathogens, the role of recurrent infection in relation to biofilm formation, and the host response at protein level will be studied in detail. This project is expected to increase the understanding of the underlying mechanisms of OM disease, which will support future treatment and prevention strategies. Better understanding in OM pathogenesis is warranted in order to develop these novel preventive strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rAOM | – | Other: questionnaire, Procedure: blood sample, Procedure: collection of middle ear fluid, Procedure: nasopharyngeal swabChildren 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion. |
| COME | – | Other: questionnaire, Procedure: blood sample, Procedure: collection of middle ear fluid, Procedure: nasopharyngeal swabChildren 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion. |
| CSOM | – | –Children 0-5 years of age suffering from chronic suppurative otitis media and waiting for tympanostomy tube insertion. Note: Only 3 patients with CSOM were recruited and therefore not suitable for publication. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion
Key inclusion criteria (4 listed)
- children up to 5 years of age
- suffering from rAOM, COME or CSOM
- waiting for tympanostomy tube insertion
- informed consent
Key exclusion criteria (4 listed)
- No informed consent
- The child has a malignancy, or organ transplantation, or immune deficiency in the medical history
- The child had recent elective ear surgery (i.e. mastoidectomy, implants <2 weeks ago)
- The child suffers from systemic infectious diseases (i.e. hepatitis, chickenpox)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireIdentification of risk factors | Other | COME, rAOM |
| blood samplevenal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months. | Procedure or surgery | COME, rAOM |
| collection of middle ear fluidDuring routine surgery middle ear fluids are collected per patient. | Procedure or surgery | COME, rAOM |
| nasopharyngeal swabA nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months. | Procedure or surgery | COME, rAOM |
Primary outcome
Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease
Time frame: 01-06-2009 to 01-06-2010
4 secondary outcomes
Otitis media demography
Time frame: 15-04-2008 to 01-01-2010
Bacterial and viral pathogen detection
Time frame: 15-04-2008 to 01-01-2010
Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens
Time frame: 15-04-08 to 01-01-2010
Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis
Time frame: 01-06-2009 to 01-06-2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
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Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
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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.
Ronald de Groot, MD, PhD study chair
Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
Kim Stol, MD principal investigator
Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
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 Otitis Media, run by Radboud University Medical Center at 2 sites in Netherlands.
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 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: status not confirmed, as of the sponsor's last update on 20 Jul 2011. 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 Netherlands. 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?
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?
Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease (time frame: 01-06-2009 to 01-06-2010). 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 20 Jul 2011.