Clinical trial NCT00847756: Host-pathogen Interaction in Otitis Media
Official title: Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 179
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion

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.


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)

Primary outcomes:
measure: Detection of biological markers in blood which inform us about the risk of recurrent infection and severity of disease
timeFrame: 01-06-2009 to 01-06-2010
Secondary outcomes:
measure: Otitis media demography
timeFrame: 15-04-2008 to 01-01-2010
measure: Bacterial and viral pathogen detection
timeFrame: 15-04-2008 to 01-01-2010
measure: Determination of the molecular and cellular immune response in relation to viral and bacterial pathogens
timeFrame: 15-04-08 to 01-01-2010
measure: Gene expression profiling of the three major bacterial pathogens: S. pneumoniae, H. influenzae and M. catarrhalis
timeFrame: 01-06-2009 to 01-06-2010
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina hospital, Department of otorhinolaryngology
city: Nijmegen
country: Netherlands
facility: Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology
Study officials:
affiliation: Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
name: Ronald de Groot, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
name: Kim Stol, MD
role: PRINCIPAL_INVESTIGATOR
References: