Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456739
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital

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.

Condition or disease
Suppurative Otitis Media

Layout table for study information
Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis Media in Pediatric Patients in Northern Israel
Estimated Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 20, 2019
Estimated Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. microbiome variability [ Time Frame: 2 years ]
    detection of microbiome differces between suppurative and non-suppurative otitis media in pediatric patients


Biospecimen Retention:   Samples Without DNA
collection of ear effusion


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients with suppurative otitis media with effusion
Criteria

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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456739


Contacts
Layout table for location contacts
Contact: saqer massuod, md 972-4-6828470 saqr.m@ziv.health.gov.il

Sponsors and Collaborators
Ziv Hospital
Investigators
Layout table for investigator information
Principal Investigator: saqer massuod, MD Ziv Medical Center

Layout table for additonal information
Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT03456739     History of Changes
Other Study ID Numbers: 0019-18-ZIV
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Otitis Media, Suppurative
Otitis
Otitis Media
Ear Diseases
Suppuration
Otorhinolaryngologic Diseases
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents