The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

NCT ID: NCT03456739

Last Updated: 2018-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-20

Study Completion Date

2020-02-20

Brief Summary

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ear swabs will be collected from 120 patients with established CSOM at the ear-nose-throat (ENT) outpatient clinic at the Ziv medical center, and 120 swabs will be taken from children with Otitis Media with Effusion (OME) undergoing elective tympanostomy tube insertion, serving as a control group. Ear swabs will be frozen at -80C until analysis.DNA will be purified from ear swabs, and amplified by PCR so that a barcoded 16S rRNA library from each subject will be generated. Using correlation analysis, we will compare between microbial compositions in chronic otorrhea patients vs. control groups.An additional ear swab will be collected from patients and cultured to test antibiotic resistance.

Detailed Description

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Conditions

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Suppurative Otitis Media

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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suppurative otitis media with effusion

No interventions assigned to this group

non suppurative otitis media with effusion

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

1 Year

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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saqer massuod, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center

Central Contacts

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saqer massuod, md

Role: CONTACT

972-4-6828470

Other Identifiers

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0019-18-ZIV

Identifier Type: -

Identifier Source: org_study_id

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