Overview

This trial is active, not recruiting.

Condition otitis media
Treatments questionnaire, blood sample, collection of middle ear fluid, nasopharyngeal swab
Sponsor Radboud University
Start date April 2008
End date September 2009
Trial size 179 participants
Trial identifier NCT00847756, EU-FP6, OMVac clinical 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
questionnaire
Identification of risk factors
blood sample
venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.
collection of middle ear fluid
During routine surgery middle ear fluids are collected per patient.
nasopharyngeal swab
A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.
Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.
questionnaire
Identification of risk factors
blood sample
venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.
collection of middle ear fluid
During routine surgery middle ear fluids are collected per patient.
nasopharyngeal swab
A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.
Children 0-5 years of age suffering from chronic suppurative otitis media and waiting for tympanostomy tube insertion. Note: Only 3 patients with CSOM were recruited and therefore not suitable for publication.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants up to 5 years old.

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)

Additional Information

Official title Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media
Principal investigator Kim Stol, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Radboud University.