Thorough clinical investigation of the host-pathogen interaction in chronic and recurrent otitis media.

Conditions: middle ear infection
otitis media
10027584
10019815

Registration Number: NL-OMON32359

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 1093

Inclusion Criteria

I.
- Patients 0-5yrs old, seen at the Out Patient Department of ENT-surgery by an ENT-specialist in the UMC St Radboud or Canius Wilhelmina Hospital with...
- Episodes of recurrent Acute Otitis Media (rAOM) OR Chronic Otitis Media with Effusion (COME) OR Chronic Suppurative Otitis Media (CSOM) AND
- Who will receive tympanostomy tubes.
II.
- Patients 0-16 yrs of age, seen at the Out Patient Department of ENT-surgery by an ENT-specialist in the UMC St Radboud or the Canisius Wilhelmina Hospital with...
- Episodes of recurrent Acute Otitis Media (rAOM) OR Chronic Otitis Media with Effusion (COME) OR Chronic Suppurative Otitis Media (CSOM) AND...
- who will undergo middle ear clean up surgery.

Exclusion Criteria

- no informed consent
- age category other than 0-5 years
- malignancies, organ transplantation in history, recent ear surgery e.g. mastoidectomy or cochlear implant (<2weeks ago)
- immunodeficiency
- current systemic infectious diseases (e.g. chickenpox, hepatitis)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PROPOSAL PART I - TYMPANOSTOMY TUBE INSERTION<br /><br>Determination of molecular and cellular immune response in relation to the<br /><br>viral and bacterial pathogens causing otitis media.<br /><br><br /><br>PROPOSAL PART II - BIOFILM FORMATION<br /><br>Gene expression profiling of the three major bacterial pathogens: S.<br /><br>pneumoniae, H. influenzae and<br /><br>M. catarrhalis present in biofilm, in comparison to in vitro cultures or middle<br /><br>ear fluid.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PROPOSAL PART I - TYMPANOSTOMY TUBE INSERTION<br /><br>Otitis Media Demography.<br /><br>Viral and Bacterial Pathogen detection.<br /><br>Gene expression profiling of the three major bacterial pathogens: S.<br /><br>pneumoniae, H. influenzae and M. catarrhalis.<br /><br><br /><br>PROPOSAL PART II - BIOFILM FORMATION<br /><br>Otitis Media Demography.<br /><br>Viral and Bacterial Pathogen detection.</p><br>