Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children

September 26, 2011 updated by: NasVax Ltd
This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 84101
        • Recruiting
        • Ben-Gurion University of the Negev
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 subjects with acute otitis media infection will be enrolled. The expectation is for ≥50 children with pneumococcal culture-positive MEF (Middle Ear Fluid) and ≥50 children with culture-negative MEF to be enrolled

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Control group - culture negative
50 children with pneumococcal culture-negative Acute Otitis Media
study group- culture positive
50 children with pneumococcal culture-positive Acute Otitis Media

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serological studies of pneumococcal proteins and their development over time following otitis media infections
Time Frame: 3 months per individual
The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.
3 months per individual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NasVax Ltd

Investigators

  • Principal Investigator: Ron Dagan, Prof. MD., Ben-Gurion University of the Negev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

October 3, 2010

First Submitted That Met QC Criteria

October 4, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NX10-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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