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Rhinosinusites Chroniques

Primary Purpose

Sinusitis, Chronic Disease, Refractory

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological sample
Sponsored by
Institut Hospitalo-Universitaire Méditerranée Infection
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service ORL et de Chirurgie Cervico - Faciale/ AP-HMRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

biological sample

Arm Description

Genomic & culturomic analyses

Outcomes

Primary Outcome Measures

Sinusian microbiota description
species, number and type of isolated microbes

Secondary Outcome Measures

Full Information

First Posted
March 30, 2015
Last Updated
March 30, 2015
Sponsor
Institut Hospitalo-Universitaire Méditerranée Infection
Collaborators
University Hospital, Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02407275
Brief Title
Rhinosinusites Chroniques
Official Title
ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Hospitalo-Universitaire Méditerranée Infection
Collaborators
University Hospital, Marseille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Chronic Disease, Refractory

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
biological sample
Arm Type
Other
Arm Description
Genomic & culturomic analyses
Intervention Type
Other
Intervention Name(s)
Biological sample
Primary Outcome Measure Information:
Title
Sinusian microbiota description
Description
species, number and type of isolated microbes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erwan Le Dault
Phone
0033699662257
Email
erwan.le.dault@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Edouard Fournier, Professor
Email
pierre-edouard.fournier@univ-amu.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Edouard Fournier, Professor
Organizational Affiliation
IHU Méditerranée Infection
Official's Role
Study Chair
Facility Information:
Facility Name
Service ORL et de Chirurgie Cervico - Faciale/ AP-HM
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Edouard Fournier
Phone
04 91 38 55 17
Email
pierre-edouard.fournier@univ-amu.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Edouard Fournier
First Name & Middle Initial & Last Name & Degree
Justin Michel
First Name & Middle Initial & Last Name & Degree
Patrick Dessi
First Name & Middle Initial & Last Name & Degree
Martin Penicaud
First Name & Middle Initial & Last Name & Degree
Michael Achache
First Name & Middle Initial & Last Name & Degree
Arnaud Paganelli

12. IPD Sharing Statement

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Rhinosinusites Chroniques

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