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Clinical Trials/NCT00847756
NCT00847756UnknownNot Applicable

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

Radboud University Medical Center2 sites in 1 country179 target enrollmentStarted: April 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
179
Locations
2
Primary Endpoint
Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (2)

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