NCT01157910

Brief Summary

Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections. The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 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

First Submitted

Initial submission to the registry

July 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

July 4, 2010

Last Update Submit

July 6, 2010

Conditions

Chronic Otitis MediaAge Determined Bacteria

Keywords

Ear infectionChronic

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children suffering from chronic otitis media who are scheduled for surgery.

You may qualify if:

  • All children with chronic ear infections scheduled for surgical interventions

You may not qualify if:

  • Children who have undergone prior mastoid surgery, or children with oncologic treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe MC,

Hadera, Israel

Location

MeSH Terms

Conditions

OtitisBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 4, 2010

First Posted

July 7, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

IL(1)