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Host-pathogen Interaction in Otitis Media

NCT00847756 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 179

Last updated 2011-07-20

No results posted yet for this study

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.

Conditions

  • Otitis Media

Interventions

OTHER

questionnaire

Identification of risk factors

PROCEDURE

blood sample

venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.

PROCEDURE

collection of middle ear fluid

During routine surgery middle ear fluids are collected per patient.

PROCEDURE

nasopharyngeal swab

A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Ronald de Groot, MD, PhD · Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

  • Kim Stol, MD · Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-09-30
Completion
2011-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00847756 on ClinicalTrials.gov