Host-pathogen Interaction in Otitis Media

NCT00847756 | Unknown

• 2 other identifiers: OMVac clinical studyEU-FP6
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 2

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.

Conditions

Otitis Media

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

rAOM

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

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.

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.

Interventions

questionnaire OTHER

Identification of risk factors

COME; rAOM

blood sample PROCEDURE

venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.

COME; rAOM

collection of middle ear fluid PROCEDURE

During routine surgery middle ear fluids are collected per patient.

COME; rAOM

nasopharyngeal swab PROCEDURE

A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.

COME; rAOM

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• children up to 5 years of age
• suffering from rAOM, COME or CSOM
• waiting for tympanostomy tube insertion
• informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

Canisius Wilhelmina hospital, Department of otorhinolaryngology

Nijmegen, 6500 HB, Netherlands

Location

Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology

Nijmegen, 6500 HB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood nasopharyngeal swab middle ear fluid

MeSH Terms

Conditions

Otitis Media; Haemophilus Infections

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Ronald de Groot, MD, PhD

  Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

  STUDY CHAIR

• Kim Stol, MD

  Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: July 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2010-12

Locations

NL (2)