Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
NCT ID: NCT01214538
Last Updated: 2011-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2010-10-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control group - culture negative
50 children with pneumococcal culture-negative Acute Otitis Media
No interventions assigned to this group
study group- culture positive
50 children with pneumococcal culture-positive Acute Otitis Media
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients can be either ambulatory or hospitalized.
* Presenting with acute otitis media.
* Tympanocentesis was performed at least in one ear for a clinical indication.
* Culture of middle ear fluid was obtained.
* Parents agreeing to participate in the study and to submit their children for follow-up, blood test and nasopharyngeal/oropharyngeal (NP/OP) cultures.
Exclusion Criteria
* Known immunodeficiency.
* Known previous recent pneumococcal infections (\<1 month prior to current visit).
3 Months
3 Years
ALL
No
Sponsors
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NasVax Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ron Dagan, Prof. MD.
Role: PRINCIPAL_INVESTIGATOR
Ben-Gurion University of the Negev
Locations
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Ben-Gurion University of the Negev
Beersheba, , Israel
Countries
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Facility Contacts
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Other Identifiers
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NX10-07
Identifier Type: -
Identifier Source: org_study_id