NCT01214538

Brief Summary

This clinical study is designed to assess prospectively the sero-responses to various proteins in cases of pneumococcal Acute Otitis Media.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

3.4 years

First QC Date

October 3, 2010

Last Update Submit

September 26, 2011

Conditions

Acute Otitis Media

Keywords

Vaccine pneumococcal natural history Acute otitis media

Outcome Measures

Primary Outcomes (1)

  • Serological studies of pneumococcal proteins and their development over time following otitis media infections

    The serological studies will study the natural immune response to protective pneumococcal vaccine antigens.

    3 months per individual

Study Arms (2)

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

Eligibility Criteria

Age3 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben-Gurion University of the Negev

Beersheba, 84101, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ron Dagan, Prof. MD.

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2010

First Posted

October 5, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2014

Study Completion

July 1, 2014

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

IL(1)