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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32359
Enrollment
1093
Registered
2008-01-14
Start date
2007-11-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

middle ear infection otitis media

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

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

Secondary

MeasureTime frame
PROPOSAL PART I - TYMPANOSTOMY TUBE INSERTION Otitis Media Demography. Viral and Bacterial Pathogen detection. Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis. PROPOSAL PART II - BIOFILM FORMATION Otitis Media Demography. Viral and Bacterial Pathogen detection.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)