Host-pathogen Interaction in Otitis Media (OMVac)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00847756
First received: February 18, 2009
Last updated: July 19, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention
Otitis Media
Other: questionnaire
Procedure: blood sample
Procedure: collection of middle ear fluid
Procedure: nasopharyngeal swab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Otitis media demography [ Time Frame: 15-04-2008 to 01-01-2010 ] [ Designated as safety issue: No ]
  • Bacterial and viral pathogen detection [ Time Frame: 15-04-2008 to 01-01-2010 ] [ Designated as safety issue: No ]
  • Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens [ Time Frame: 15-04-08 to 01-01-2010 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood nasopharyngeal swab middle ear fluid


Enrollment: 179
Study Start Date: April 2008
Estimated Study Completion Date: July 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847756

Locations
Netherlands
Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology
Nijmegen, Netherlands, 6500 HB
Canisius Wilhelmina hospital, Department of otorhinolaryngology
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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
  More Information

No publications provided

Responsible Party: Prof. dr. R. de Groot, head department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
ClinicalTrials.gov Identifier: NCT00847756     History of Changes
Other Study ID Numbers: OMVac clinical study, EU-FP6
Study First Received: February 18, 2009
Last Updated: July 19, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Otitis media
demography
Streptococcus pneumoniae
Haemophilus influenzae
Moraxella catarrhalis
rhinovirus
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:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014