Host-pathogen Interaction in Otitis Media

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Other: questionnaire
* Procedure: blood sample
* Procedure: collection of middle ear fluid
* Procedure: nasopharyngeal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rAOM<br>Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion. | Other: questionnaire<br>* Identification of risk factors<br>Procedure: blood sample<br>* venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.<br>Procedure: collection of middle ear fluid<br>* During routine surgery middle ear fluids are collected per patient.<br>Procedure: nasopharyngeal swab<br>* A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.<br>|
| COME<br>Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion. | Other: questionnaire<br>* Identification of risk factors<br>Procedure: blood sample<br>* venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.<br>Procedure: collection of middle ear fluid<br>* During routine surgery middle ear fluids are collected per patient.<br>Procedure: nasopharyngeal swab<br>* A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.<br>|
| CSOM<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease |  | 01-06-2009 to 01-06-2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Otitis media demography |  | 15-04-2008 to 01-01-2010 | 
| Bacterial and viral pathogen detection |  | 15-04-2008 to 01-01-2010 | 
| Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens |  | 15-04-08 to 01-01-2010 | 
| Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis |  | 01-06-2009 to 01-06-2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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