Host-pathogen Interaction in Otitis Media (OMVac)

Radboud University Medical Center

Status: Unknown

Conditions: Otitis Media

Treatments: Procedure: blood sample; Procedure: nasopharyngeal swab; Procedure: collection of middle ear fluid; Other: questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT00847756

OMVac clinical study

EU-FP6 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design

179 participants in 3 patient groups

rAOM

Description:

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

Treatment:

Other: questionnaire

Procedure: blood sample

Procedure: nasopharyngeal swab

Procedure: collection of middle ear fluid

COME

Description:

Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.

Treatment:

Other: questionnaire

Procedure: blood sample

Procedure: nasopharyngeal swab

Procedure: collection of middle ear fluid

CSOM

Description:

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.