Host-pathogen Interaction in Otitis Media (OMVac)

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

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 Overview

• Status: Unknown
• Conditions: Otitis Media
• Intervention / Treatment: Other: questionnaire; Procedure: blood sample; Procedure: collection of middle ear fluid; Procedure: nasopharyngeal swab

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Canisius Wilhelmina hospital, Department of otorhinolaryngology
  • Nijmegen, Netherlands, 6500 HB
    • Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rAOM; Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.	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.
COME; Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.	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.
CSOM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease	01-06-2009 to 01-06-2010

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Study Chair: Ronald de Groot, MD, PhD, Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands; Principal Investigator: Kim Stol, MD, Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): July 20, 2011
• Last Update Submitted That Met QC Criteria: July 19, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Streptococcus pneumoniae; Otitis media; Haemophilus influenzae; Moraxella catarrhalis; rhinovirus; demography; children, 0-5 years of age; diagnosed rAOM, COME or CSOM by an otorhinolaryngologist; primary and secondary hospital Nijmegen, the Netherlands
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: OMVac clinical study; EU-FP6 (Registry Identifier: 037653)