The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis Media in Pediatric Patients in Northern Israel

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.

Study Overview

• Status: Unknown
• Conditions: Suppurative Otitis Media

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: saqer massuod, md; Phone Number: 972-4-6828470; Email: saqr.m@ziv.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

pediatric patients with suppurative otitis media with effusion

Description

Inclusion otitis media with effusion,parental informed consent, age between 1 - 9 years, no known immune deficient disorder -

Exclusion Criteria:no parental consent, known immune disorder, current acute otitis media.

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
suppurative otitis media with effusion
non suppurative otitis media with effusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiome variability	detection of microbiome differces between suppurative and non-suppurative otitis media in pediatric patients	2 years

Collaborators and Investigators

• Sponsor: Ziv Hospital
• Investigators: Principal Investigator: saqer massuod, MD, Ziv Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2018
• Primary Completion (Anticipated): April 20, 2019
• Study Completion (Anticipated): February 20, 2020

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Otorhinolaryngologic Diseases; Ear Diseases; Infections; Otitis; Otitis Media; Suppuration; Otitis Media, Suppurative
• Other Study ID Numbers: 0019-18-ZIV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No