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Trial record 37 of 437 for:    OTITIS

Host-pathogen Interaction in Otitis Media (OMVac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00847756
Recruitment Status : Unknown
Verified December 2010 by Radboud University.
Recruitment status was:  Active, not recruiting
First Posted : February 19, 2009
Last Update Posted : July 20, 2011
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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