Rhinosinusites Chroniques
Primary Purpose
Sinusitis, Chronic Disease, Refractory
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological sample
Sponsored by
About this trial
This is an interventional screening trial for Sinusitis
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
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
NCT ID
NCT02407275
First Posted
March 30, 2015
Last Updated
March 30, 2015
Sponsor
Institut Hospitalo-Universitaire Méditerranée Infection
Collaborators
University Hospital, Marseille
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
Learn more about this trial
Rhinosinusites Chroniques
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