Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Information source: NasVax Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Media
Phase: N/A
Status: Recruiting
Sponsored by: NasVax Ltd Official(s) and/or principal investigator(s): Ron Dagan, Prof. MD., Principal Investigator, Affiliation: Ben-Gurion University of the Negev
Summary
This clinical study is designed to assess prospectively the sero-responses to various
proteins in cases of pneumococcal Acute Otitis Media.
Clinical Details
Official title: Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Serological studies of pneumococcal proteins and their development over time following otitis media infections
Eligibility
Minimum age: 3 Months.
Maximum age: 3 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female Jewish and Bedouin children.
- 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:
- Having another infection that is likely to be caused by S. pneumoniae.
- Known immunodeficiency.
- Known previous recent pneumococcal infections (<1 month prior to current visit).
Locations and Contacts
Ben-Gurion University of the Negev, Beer Sheva 84101, Israel; Recruiting Ron Dagan, Prof MD, Phone: +972 + 8-6400547, Email: rdagan@bgu.ac.il
Additional Information
Starting date: October 2010
Last updated: September 26, 2011
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