Rhinosinusites Chroniques

March 30, 2015 updated by: Institut Hospitalo-Universitaire Méditerranée Infection

ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE

To analyse and describe sinus microbiota, during hard to treat (or refractory) rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA contained in samples).

Samples are middle meatus swabs or pus aspiration, done during usually patient following.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Marseille, France
        • Recruiting
        • Service ORL et de Chirurgie Cervico - Faciale/ AP-HM
        • Principal Investigator:
          • Justin Michel
        • Contact:
        • Sub-Investigator:
          • Pierre-Edouard Fournier
        • Sub-Investigator:
          • Patrick Dessi
        • Sub-Investigator:
          • Martin Penicaud
        • Sub-Investigator:
          • Michael Achache
        • Sub-Investigator:
          • Arnaud Paganelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 year old
  • chronic refractory rhinosinusitis
  • to require middle meatus swab or other sinus sample
  • absence of opposition

Exclusion Criteria:

  • <18 year old
  • pregnant women
  • breastfeeding
  • under trusteeship
  • under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: biological sample
Genomic & culturomic analyses
Other: Biological sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinusian microbiota description
Time Frame: 6 months
species, number and type of isolated microbes
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Hospitalo-Universitaire Méditerranée Infection

Collaborators

University Hospital, Marseille

Investigators

  • Study Chair: Pierre-Edouard Fournier, Professor, IHU Méditerranée infection

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHU Méditerranée Infections

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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