NCT03456739

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

March 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 28, 2018

Last Update Submit

February 28, 2018

Conditions

Suppurative Otitis Media

Outcome Measures

Primary Outcomes (1)

  • microbiome variability

    detection of microbiome differces between suppurative and non-suppurative otitis media in pediatric patients

    2 years

Study Arms (2)

suppurative otitis media with effusion

non suppurative otitis media with effusion

Eligibility Criteria

Age1 Year - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients with suppurative otitis media with effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

collection of ear effusion

MeSH Terms

Conditions

Otitis Media, Suppurative

Condition Hierarchy (Ancestors)

SuppurationInfectionsOtitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • saqer massuod, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

saqer massuod, md

CONTACT

972-4-6828470saqr.m@ziv.health.gov.il

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

April 20, 2018

Primary Completion

April 20, 2019

Study Completion

February 20, 2020

Last Updated

March 7, 2018

Record last verified: 2018-02