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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

Page last updated: August 23, 2015

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