Host-pathogen Interaction in Otitis Media

Otitis Media Clinical Trial

— OMVac  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00847756
• Other study ID #: OMVac clinical study
• Secondary ID: EU-FP6
• Status: Active, not recruiting
• Phase: N/A
• First received: February 18, 2009
• Last updated: July 19, 2011
• Start date: April 2008
• Est. completion date: July 2011

Study information

• Verified date: December 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: July 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Otitis
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina hospital, Department of otorhinolaryngology	Nijmegen
Netherlands	Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Otitis media demography		15-04-2008 to 01-01-2010	No
Secondary	Bacterial and viral pathogen detection		15-04-2008 to 01-01-2010	No
Secondary	Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens		15-04-08 to 01-01-2010	No
Secondary	Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis		01-06-2009 to 01-06-2010	No