Host-pathogen Interaction in Otitis Media (OMVac)
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Otitis Media |
Other: questionnaire Procedure: blood sample Procedure: collection of middle ear fluid Procedure: nasopharyngeal swab |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media |
- 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 ] [ Designated as safety issue: No ]
- Otitis media demography [ Time Frame: 15-04-2008 to 01-01-2010 ] [ Designated as safety issue: No ]
- Bacterial and viral pathogen detection [ Time Frame: 15-04-2008 to 01-01-2010 ] [ Designated as safety issue: No ]
- Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens [ Time Frame: 15-04-08 to 01-01-2010 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood nasopharyngeal swab middle ear fluid
| Enrollment: | 179 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | July 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
rAOM
Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
|
Other: questionnaire
Identification of risk factors
Procedure: blood sample
venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.
Procedure: collection of middle ear fluid
During routine surgery middle ear fluids are collected per patient.
Procedure: nasopharyngeal swab
A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.
|
|
COME
Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.
|
Other: questionnaire
Identification of risk factors
Procedure: blood sample
venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.
Procedure: collection of middle ear fluid
During routine surgery middle ear fluids are collected per patient.
Procedure: nasopharyngeal swab
A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.
|
|
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.
|
Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion
Inclusion Criteria:
- children up to 5 years of age
- suffering from rAOM, COME or CSOM
- waiting for tympanostomy tube insertion
- informed consent
Exclusion Criteria:
- 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)
Contacts and Locations| Netherlands | |
| Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology | |
| Nijmegen, Netherlands, 6500 HB | |
| Canisius Wilhelmina hospital, Department of otorhinolaryngology | |
| Nijmegen, Netherlands, 6500 HB | |
| Study Chair: | Ronald de Groot, MD, PhD | Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands |
| Principal Investigator: | Kim Stol, MD | Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands |
More Information
No publications provided
| Responsible Party: | Prof. dr. R. de Groot, head department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands |
| ClinicalTrials.gov Identifier: | NCT00847756 History of Changes |
| Other Study ID Numbers: | OMVac clinical study, EU-FP6 |
| Study First Received: | February 18, 2009 |
| Last Updated: | July 19, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Radboud University:
|
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 |
Additional relevant MeSH terms:
|
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013