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Clinical Trials/NCT00847756
NCT00847756
Unknown
Not Applicable

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

Radboud University Medical Center2 sites in 1 country179 target enrollmentApril 2008
ConditionsOtitis Media

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otitis Media
Sponsor
Radboud University Medical Center
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
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
July 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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)

Study Sites (2)

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