Clinical Trial: Host-pathogen Interaction in Otitis Media

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

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 Summary:
Sponsor: Radboud University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: February 18, 2009
Date Started: April 2008
Date Completion: July 2011
Last Updated: July 19, 2011
Last Verified: December 2010