Host-pathogen Interaction in Otitis Media

• Conditions: Otitis Media
• Interventions: Other: questionnaire; Procedure: blood sample; Procedure: collection of middle ear fluid; Procedure: nasopharyngeal swab

• Registration Number: NCT00847756
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2009-09
• Status Verified: 2010-12
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 179

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rAOM	questionnaire	Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
rAOM	blood sample	Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
rAOM	collection of middle ear fluid	Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
rAOM	nasopharyngeal swab	Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
COME	questionnaire	Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.
COME	blood sample	Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.
COME	collection of middle ear fluid	Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.
COME	nasopharyngeal swab	Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Bacterial and viral pathogen detection	15-04-2008 to 01-01-2010
Otitis media demography	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

Trial Locations

Locations (2)

Canisius Wilhelmina hospital, Department of otorhinolaryngology; 🇳🇱 Nijmegen, Netherlands

Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology; 🇳🇱 Nijmegen, Netherlands