Host-pathogen Interaction in Otitis Media (OMVac)

• ClinicalTrials.gov Identifier: NCT00847756
• Recruitment Status: Unknown
• First Posted: February 19, 2009
• Last Update Posted: July 20, 2011
• Sponsor: Radboud University
• Information provided by: Radboud University

Tracking Information

• First Submitted Date: February 18, 2009
• First Posted Date: February 19, 2009
• Last Update Posted Date: July 20, 2011
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 18, 2009): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00847756 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: February 18, 2009)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Host-pathogen Interaction in Otitis Media
• Official Title: Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

blood nasopharyngeal swab middle ear fluid

• Sampling Method: Probability Sample
• Study Population: Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion
• Condition: Otitis Media

Intervention

• 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.

Study Groups/Cohorts

• rAOM
  Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
  Interventions:

  • Other: questionnaire
  • Procedure: blood sample
  • Procedure: collection of middle ear fluid
  • Procedure: nasopharyngeal swab
• COME
  Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.
  Interventions:

  • Other: questionnaire
  • Procedure: blood sample
  • Procedure: collection of middle ear fluid
  • Procedure: nasopharyngeal swab
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 19, 2011): 179
• Original Estimated Enrollment (submitted: February 18, 2009): 200
• Estimated Study Completion Date: July 2011
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 5 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00847756
• Other Study ID Numbers: OMVac clinical study; EU-FP6 ( Registry Identifier: 037653 )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof. dr. R. de Groot, head department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
• Study Sponsor: Radboud University
• Collaborators: Not Provided

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

• PRS Account: Radboud University
• Verification Date: December 2010