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
|
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 |
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 |
|
||||||
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 |
|
||||||
Study Groups/Cohorts |
|
||||||
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 |
179 | ||||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
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 |
|
||||||
PRS Account | Radboud University | ||||||
Verification Date | December 2010 |