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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

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

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

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

erwan.le.dault@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre-Edouard Fournier, Professor

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

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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