NCT00847756|Unknown
Host-pathogen Interaction in Otitis Media
OMVac
Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media
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OMVac
Thorough Clinical Investigation of the Host-pathogen Interaction in Chronic and Recurrent Otitis Media
Sponsor study identifier
Secondary identifiers
REGISTRY · 037653
observational
179
1 country
2
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
July 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 18, 2009
Actual (reported)February 19, 2009
Actual (reported)September 2009
Actual (reported)July 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Children 0-5 years of age suffering from recurrent acute otitis media and waiting for tympanostomy tube insertion.
Children 0-5 years of age suffering from chronic otitis media with effusion and waiting for tympanostomy tube insertion.
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.
Identification of risk factors
venal puncture, 5ml. A blood sample will be taken at the day of surgery and after 2-3 months.
Children up to 5 years of age suffering from rAOM, COME or CSOM waiting for tympanostomy tube insertion
Canisius Wilhelmina hospital, Department of otorhinolaryngology
Nijmegen, 6500 HB, Netherlands
Radboud, University Nijmegen Medical Centre, Department of Otorhinolaryngology
Nijmegen, 6500 HB, Netherlands
blood nasopharyngeal swab middle ear fluid
Ronald de Groot, MD, PhD
Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
Kim Stol, MD
Department of Pediatrics, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands
179 participants (actual enrollment reported by the registry).
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Homeopathic Ear Drops for Otitis Media Study
During routine surgery middle ear fluids are collected per patient.
A nasopharyngeal swab is taken at the end of the surgical procedure and after 2-3 months.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 2009
Actual (reported)Study Completion
July 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 20, 2011
Record last verified: 2010-12
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Source: ClinicalTrials.gov.
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